Trial Outcomes & Findings for A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy (NCT NCT06267001)

NCT ID: NCT06267001

Last Updated: 2026-06-10

Results Overview

An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

56 participants

Primary outcome timeframe

Up to 16.4 months

Results posted on

2026-06-10

Participant Flow

A total of 56 participants with programmed death-ligand 1 (PD-L1)-positive Stage IIB, IIIA, or select IIIB (T3N2 only) non-small cell lung cancer (NSCLC) following resection and adjuvant platinum-based chemotherapy took part in the study at 35 investigative sites in 10 countries from 21 March 2024 to 16 December 2025.

Participants were randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.

Participant milestones

Participant milestones
Measure
Atezolizumab + Placebo
Participants received atezolizumab, 1680 milligrams (mg), in combination with or without placebo as intravenous (IV) co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Overall Study
STARTED
27
29
Overall Study
Safety Analysis Set (SAS)
28
24
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
27
29

Reasons for withdrawal

Reasons for withdrawal
Measure
Atezolizumab + Placebo
Participants received atezolizumab, 1680 milligrams (mg), in combination with or without placebo as intravenous (IV) co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Overall Study
Death
2
0
Overall Study
Disease Recurrence
0
1
Overall Study
Study Terminated by Sponsor
22
23
Overall Study
Withdrawal by Subject
3
5

Baseline Characteristics

A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atezolizumab + Placebo
n=27 Participants
Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
n=29 Participants
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Total
n=56 Participants
Total of all reporting groups
Age, Continuous
65.3 years
STANDARD_DEVIATION 9.3 • n=9 Participants
66.4 years
STANDARD_DEVIATION 6.8 • n=27 Participants
65.9 years
STANDARD_DEVIATION 8.1 • n=267 Participants
Sex: Female, Male
Female
6 Participants
n=9 Participants
8 Participants
n=27 Participants
14 Participants
n=267 Participants
Sex: Female, Male
Male
21 Participants
n=9 Participants
21 Participants
n=27 Participants
42 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=9 Participants
3 Participants
n=27 Participants
5 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=9 Participants
26 Participants
n=27 Participants
51 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Asian
22 Participants
n=9 Participants
20 Participants
n=27 Participants
42 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
White
4 Participants
n=9 Participants
9 Participants
n=27 Participants
13 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants

PRIMARY outcome

Timeframe: Up to 16.4 months

Population: SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.

An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.

Outcome measures

Outcome measures
Measure
Atezolizumab ± Placebo
n=28 Participants
Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
n=24 Participants
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Number of Participants With Adverse Events (AEs)
26 Participants
21 Participants

Adverse Events

Atezolizumab ± Placebo

Serious events: 5 serious events
Other events: 23 other events
Deaths: 2 deaths

Tiragolumab + Atezolizumab

Serious events: 9 serious events
Other events: 21 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Atezolizumab ± Placebo
n=28 participants at risk
Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
n=24 participants at risk
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Cardiac disorders
Sinus node dysfunction
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Gastrointestinal disorders
Gastrointestinal haemorrhage
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
COVID-19
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Febrile infection
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Pharyngitis
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Pneumonia
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Pulmonary tuberculosis
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Injury, poisoning and procedural complications
Post procedural inflammation
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Nervous system disorders
Encephalitis autoimmune
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Renal and urinary disorders
Nephritis
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Respiratory, thoracic and mediastinal disorders
Lung consolidation
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.

Other adverse events

Other adverse events
Measure
Atezolizumab ± Placebo
n=28 participants at risk
Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Tiragolumab + Atezolizumab
n=24 participants at risk
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity.
Blood and lymphatic system disorders
Anaemia
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Endocrine disorders
Hyperthyroidism
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Endocrine disorders
Hypothyroidism
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
16.7%
4/24 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Gastrointestinal disorders
Constipation
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Gastrointestinal disorders
Diarrhoea
7.1%
2/28 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
General disorders
Fatigue
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
12.5%
3/24 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
General disorders
Pyrexia
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
COVID-19
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
12.5%
3/24 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Influenza
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Infections and infestations
Upper respiratory tract infection
3.6%
1/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Injury, poisoning and procedural complications
Fall
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
12.5%
3/24 • Number of events 6 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Alanine aminotransferase increased
10.7%
3/28 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Aspartate aminotransferase increased
10.7%
3/28 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Blood cholesterol increased
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Blood creatine phosphokinase increased
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Blood creatinine increased
14.3%
4/28 • Number of events 7 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Investigations
Platelet count decreased
14.3%
4/28 • Number of events 5 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Metabolism and nutrition disorders
Hypercholesterolaemia
7.1%
2/28 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Metabolism and nutrition disorders
Hyperglycaemia
7.1%
2/28 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Metabolism and nutrition disorders
Hyperuricaemia
7.1%
2/28 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Arthralgia
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
20.8%
5/24 • Number of events 5 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Back pain
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Myalgia
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
16.7%
4/24 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Nervous system disorders
Dizziness
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Nervous system disorders
Memory impairment
0.00%
0/28 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Respiratory, thoracic and mediastinal disorders
Cough
7.1%
2/28 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
4.2%
1/24 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Skin and subcutaneous tissue disorders
Eczema
3.6%
1/28 • Number of events 1 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
8.3%
2/24 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Skin and subcutaneous tissue disorders
Pruritus
10.7%
3/28 • Number of events 4 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
41.7%
10/24 • Number of events 10 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Skin and subcutaneous tissue disorders
Rash
10.7%
3/28 • Number of events 3 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
29.2%
7/24 • Number of events 8 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
Vascular disorders
Hypertension
7.1%
2/28 • Number of events 2 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
0.00%
0/24 • Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: Hoffmann-La Roche

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