Trial Outcomes & Findings for Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (NCT NCT06502977)

Last Updated: 2026-04-15

Results Overview

ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off

Results posted on

2026-04-15

Participant Flow

Participants were enrolled at 12 trial centers in China from 27 August 2024. The trial is ongoing, he primary analysis data is presented based on the database snapshot date of 30 April 2025.

Chinese participants with advanced small cell lung cancer (SCLC) who had progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a programmed cell death 1 \[PD-1\]/programmed death ligand 1 \[PD-L1\]) and at least 1 other prior line of therapy received tarlatamab.

Participant milestones

Participant milestones
Measure	Tarlatamab Participants received tarlatamab as an intravenous (IV) infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and every 2 weeks (Q2W) thereafter. Each cycle was 28 days.
Overall Study STARTED	32
Overall Study Participants Who Received Tarlatamab	31
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Tarlatamab Participants received tarlatamab as an intravenous (IV) infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and every 2 weeks (Q2W) thereafter. Each cycle was 28 days.
Overall Study Ongoing in the study	29
Overall Study Death	3

Baseline Characteristics

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tarlatamab n=31 Participants Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days.
Age, Continuous	58.0 years STANDARD_DEVIATION 6.2 • n=193 Participants
Sex: Female, Male Female	5 Participants n=193 Participants
Sex: Female, Male Male	26 Participants n=193 Participants
Race/Ethnicity, Customized Asian	31 Participants n=193 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	31 Participants n=193 Participants

PRIMARY outcome

Timeframe: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off

Population: The safety analysis set consisted of all participants who received at least 1 dose of tarlatamab.

Outcome measures

Outcome measures
Measure	Tarlatamab n=31 Participants Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days.
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	38.7 percentage of participants Interval 21.8 to 57.8

SECONDARY outcome

Timeframe: Approximately 24 months

DOR was defined as time from the first documentation of OR until the first documentation of disease progression (PD) or death due to any cause, whichever occured first. Only participants who had achieved OR were evaluated for DOR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have reduction in short axis to \<10 mm, NOT total disappearance. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

DC was defined as CR + PR + stable disease (SD). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrate an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to \<10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

PFS was defined as the time from first dose of tarlatamab until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

ORR based on investigator assessment was defined as the percentage of participants with BOR of CR plus PR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

DOR was defined as time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first. Only participants who had achieved OR would be evaluated for DOR. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

DC was defined as CR + PR + SD. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

PFS was defined as time from enrollment until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

OS was defined as time from the first dose of tarlatamab until death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were defined as AEs starting on or after the first dose of tarlatamab up to the safety follow-up (SFU) visit or 60 days after the last dose of tarlatamab, whichever was later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

Ctrough of tarlatamab was calculated using standard noncompartmental methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 24 months

Number of participants with anti-tarlatamab (binding and neutralizing) antibodies was presented.

Outcome measures

Outcome data not reported

Adverse Events

Tarlatamab

Serious events: 7 serious events

Other events: 31 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Tarlatamab n=31 participants at risk Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Immune system disorders Cytokine release syndrome	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.

Other adverse events

Other adverse events
Measure	Tarlatamab n=31 participants at risk Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days.
Blood and lymphatic system disorders Anaemia	38.7% 12/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Blood and lymphatic system disorders Coagulopathy	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Blood and lymphatic system disorders Leukopenia	22.6% 7/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Blood and lymphatic system disorders Lymphopenia	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Blood and lymphatic system disorders Neutropenia	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Cardiac disorders Supraventricular extrasystoles	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Endocrine disorders Immune-mediated hypothyroidism	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Abdominal distension	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Constipation	25.8% 8/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Diarrhoea	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Glossitis	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Nausea	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Vomiting	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Chest discomfort	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Chest pain	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Fatigue	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Influenza like illness	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Localised oedema	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Non-cardiac chest pain	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Oedema peripheral	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Pain	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Peripheral swelling	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Pyrexia	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
General disorders Systemic inflammatory response syndrome	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Hepatobiliary disorders Hepatic function abnormal	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Hepatobiliary disorders Hypertransaminasaemia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Immune system disorders Cytokine release syndrome	77.4% 24/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Immune system disorders Hypersensitivity	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Infections and infestations Pneumonia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Infections and infestations Upper respiratory tract infection	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Infections and infestations Urinary tract infection	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Alanine aminotransferase increased	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Alpha hydroxybutyrate dehydrogenase increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Amylase increased	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Aspartate aminotransferase increased	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Bile acids increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Blood alkaline phosphatase increased	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Blood fibrinogen increased	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Blood glucose increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Blood lactate dehydrogenase increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Blood urea increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Electrocardiogram QT prolonged	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Fibrin D dimer increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Gamma-glutamyltransferase increased	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Lipase increased	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Liver function test abnormal	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Lymphocyte count decreased	22.6% 7/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Neutrophil count decreased	29.0% 9/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Platelet count decreased	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Urinary occult blood positive	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Urobilinogen urine increased	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Weight decreased	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations White blood cell count decreased	29.0% 9/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations White blood cells urine positive	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Decreased appetite	22.6% 7/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypercholesterolaemia	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hyperglycaemia	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hyperlipidaemia	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hyperuricaemia	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypoalbuminaemia	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypocalcaemia	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypochloraemia	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypokalaemia	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypomagnesaemia	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hyponatraemia	16.1% 5/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypophosphataemia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypoproteinaemia	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Malnutrition	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Dizziness	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Dysgeusia	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Headache	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Hypergeusia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Hypoaesthesia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Nervous system disorders Intercostal neuralgia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Psychiatric disorders Initial insomnia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Psychiatric disorders Insomnia	9.7% 3/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Reproductive system and breast disorders Prostatic calcification	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Cough	19.4% 6/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Alopecia	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Erythema	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Pruritus	12.9% 4/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Rash	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Vascular disorders Deep vein thrombosis	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Vascular disorders Hypertension	6.5% 2/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Vascular disorders Hypotension	3.2% 1/31 • For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER