Trial Outcomes & Findings for A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT03563716)

Last Updated: 2026-05-04

Results Overview

ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

135 participants

Primary outcome timeframe

From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)

Results posted on

2026-05-04

Participant Flow

A total of 135 participants with previously untreated, locally advanced, unresectable, or metastatic programmed death-ligand 1 (PD-L1)-selected non-small cell lung cancer (NSCLC) took part in the study at 39 investigative sites across 6 countries from 08 Aug 2018 to 14 Nov 2025.

Participants were randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.

Participant milestones

Participant milestones
Measure	Placebo + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 milligrams (mg), and placebo as intravenous (IV) infusions, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Overall Study STARTED	68	67
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	68	67

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 milligrams (mg), and placebo as intravenous (IV) infusions, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Overall Study Death	57	51
Overall Study Lost to Follow-up	2	0
Overall Study Study Ended by Sponsor	6	14
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg, and placebo as IV infusions, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Total n=135 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 9.9 • n=54 Participants	65.8 years STANDARD_DEVIATION 10.4 • n=60 Participants	66.4 years STANDARD_DEVIATION 10.1 • n=114 Participants
Sex: Female, Male Female	20 Participants n=54 Participants	28 Participants n=60 Participants	48 Participants n=114 Participants
Sex: Female, Male Male	48 Participants n=54 Participants	39 Participants n=60 Participants	87 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=54 Participants	1 Participants n=60 Participants	1 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=54 Participants	60 Participants n=60 Participants	123 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=54 Participants	6 Participants n=60 Participants	11 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Asian	23 Participants n=54 Participants	18 Participants n=60 Participants	41 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Black or African American	0 Participants n=54 Participants	0 Participants n=60 Participants	0 Participants n=114 Participants
Race (NIH/OMB) White	40 Participants n=54 Participants	42 Participants n=60 Participants	82 Participants n=114 Participants
Race (NIH/OMB) More than one race	1 Participants n=54 Participants	0 Participants n=60 Participants	1 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=54 Participants	7 Participants n=60 Participants	11 Participants n=114 Participants

PRIMARY outcome

Timeframe: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)

Population: ITT population included all participants randomized in the study.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Objective Response Rate (ORR)	31.3 percentage of participants Interval 19.49 to 43.2	16.2 percentage of participants Interval 6.69 to 25.66

PRIMARY outcome

Timeframe: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)

Population: ITT population included all participants randomized in the study.

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Progression-free Survival (PFS)	5.42 months Interval 4.21 to Upper limit of 95% CI was not estimable as participants without documentation of PD were censored.	3.58 months Interval 2.73 to 4.44

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: ITT population included all participants randomized in the study. Overall number analyzed is the number of participants who achieved the best confirmed OR (CR or PR).

DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=26 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=14 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Duration of Objective Response (DOR)	17.6 months Interval 9.1 to 26.1	10.7 months Interval 6.0 to 18.8

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: ITT population included all participants randomized in the study.

OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Overall Survival (OS)	23.2 months Interval 14.1 to 31.5	14.5 months Interval 9.6 to 20.4

SECONDARY outcome

Timeframe: From initiation of study drug up to approximately 83.7 months

Population: Safety-evaluable population included all randomized participants who received at least one dose of tiragolumab, placebo or atezolizumab.

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Number of Participants With Adverse Events (AEs)	66 Participants	66 Participants

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

Population: Tiragolumab pharmacokinetic (PK) evaluable population included all randomized participants who received at least one dose of tiragolumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=64 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Minimum Serum Concentration (Cmin) of Tiragolumab Predose on Cycle 1 Day 1	—	18.6 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 155.0
Minimum Serum Concentration (Cmin) of Tiragolumab Predose on Cycle 3 Day 1	—	37.9 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 67.8
Minimum Serum Concentration (Cmin) of Tiragolumab Predose on Cycle 11 Day 1	—	63.8 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 46.3

SECONDARY outcome

Timeframe: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

Population: Atezolizumab PK evaluable population included all randomized participants who received at least one dose of atezolizumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=64 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=63 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Cmin of Atezolizumab Predose on Cycle 1 Day 1	57.9 μg/mL Geometric Coefficient of Variation 147.0	69.8 μg/mL Geometric Coefficient of Variation 48.3
Cmin of Atezolizumab Predose on Cycle 3 Day 1	95.5 μg/mL Geometric Coefficient of Variation 300.5	114 μg/mL Geometric Coefficient of Variation 72.8
Cmin of Atezolizumab Predose on Cycle 11 Day 1	192 μg/mL Geometric Coefficient of Variation 40.3	181 μg/mL Geometric Coefficient of Variation 52.1

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: ADA population included all participants with any ADA assessments, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis.

Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=66 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab	—	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 36 months

Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=66 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.	Tiragolumab + Atezolizumab n=65 Participants Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria.
Number of Participants With Treatment-Emergent ADAs to Atezolizumab	24 Participants	28 Participants

Adverse Events

Placebo + Atezolizumab

Serious events: 28 serious events

Other events: 59 other events

Deaths: 57 deaths

Tiragolumab + Atezolizumab

Serious events: 40 serious events

Other events: 63 other events

Deaths: 51 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER