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: 2026-01-20

Results Overview

ORR, 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: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

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

2026-01-20

Participant Flow

Participants were recruited at study sites in 6 countries.

Eligible patients with previously untreated, locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC) were randomized 1:1 to receive either placebo plus atezolizumab or tiragolumab plus atezolizumab.

Participant milestones

Participant milestones
Measure	Placebo + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
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 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Tiragolumab + Atezolizumab Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Overall Study Death	20	14
Overall Study Withdrawal by Subject	3	3
Overall Study Still on Study	45	50

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 administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Total n=135 Participants Total of all reporting groups
Age, Continuous	67.0 Years STANDARD_DEVIATION 9.9 • n=37 Participants	65.8 Years STANDARD_DEVIATION 10.4 • n=44 Participants	66.4 Years STANDARD_DEVIATION 10.1 • n=40 Participants
Sex: Female, Male Female	20 Participants n=37 Participants	28 Participants n=44 Participants	48 Participants n=40 Participants
Sex: Female, Male Male	48 Participants n=37 Participants	39 Participants n=44 Participants	87 Participants n=40 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=37 Participants	1 Participants n=44 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	63 Participants n=37 Participants	60 Participants n=44 Participants	123 Participants n=40 Participants
Race/Ethnicity, Customized Not Stated	5 Participants n=37 Participants	4 Participants n=44 Participants	9 Participants n=40 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=37 Participants	7 Participants n=44 Participants	11 Participants n=40 Participants
Race/Ethnicity, Customized Asian	23 Participants n=37 Participants	18 Participants n=44 Participants	41 Participants n=40 Participants
Race/Ethnicity, Customized White	40 Participants n=37 Participants	42 Participants n=44 Participants	82 Participants n=40 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=37 Participants	0 Participants n=44 Participants	1 Participants n=40 Participants

PRIMARY outcome

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

Population: Intent-to-Treat (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 administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Placebo + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
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, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).

Outcome measures

Outcome measures
Measure	Tiragolumab + Atezolizumab n=67 Participants Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Placebo + Atezolizumab n=68 Participants Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Progression Free Survival (PFS)	5.42 months Interval 4.21 to 95% Confidence Interval (CI) was not estimable as participants without documentation of progressive disease (PD) were censored.	3.58 months Interval 2.73 to 4.44

SECONDARY outcome

Timeframe: Up to 6 years

DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

OS, defined as the time from randomization to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)

Outcome measures

Outcome data not reported

Adverse Events

Placebo + Atezolizumab

Serious events: 24 serious events

Other events: 58 other events

Deaths: 20 deaths

Tiragolumab + Atezolizumab

Serious events: 23 serious events

Other events: 60 other events

Deaths: 15 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

Measure	Placebo + Atezolizumab n=68 participants at risk Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.	Tiragolumab + Atezolizumab n=67 participants at risk Participants received atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Blood and lymphatic system disorders Anaemia	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	10.4% 7/67 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Endocrine disorders Hypothyroidism	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	4.4% 3/68 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Gastrointestinal disorders Constipation	13.2% 9/68 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	13.4% 9/67 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	14.7% 10/68 • Number of events 11 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	13.4% 9/67 • Number of events 12 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Gastrointestinal disorders Nausea	10.3% 7/68 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	8.8% 6/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
General disorders Asthenia	25.0% 17/68 • Number of events 18 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	25.4% 17/67 • Number of events 19 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
General disorders Fatigue	13.2% 9/68 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	22.4% 15/67 • Number of events 18 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
General disorders Oedema peripheral	4.4% 3/68 • Number of events 3 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	10.4% 7/67 • Number of events 10 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
General disorders Pyrexia	13.2% 9/68 • Number of events 12 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	11.9% 8/67 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Infections and infestations Respiratory tract infection	7.4% 5/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	3.0% 2/67 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	7.5% 5/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Injury, poisoning and procedural complications Infusion related reaction	10.3% 7/68 • Number of events 17 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	26.9% 18/67 • Number of events 22 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Alanine aminotransferase increased	8.8% 6/68 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	4.5% 3/67 • Number of events 3 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Amylase increased	2.9% 2/68 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 9 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Aspartate aminotransferase increased	7.4% 5/68 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	7.5% 5/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Blood creatinine increased	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	1.5% 1/67 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Lipase increased	2.9% 2/68 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Investigations Weight decreased	4.4% 3/68 • Number of events 3 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	17.6% 12/68 • Number of events 12 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	16.4% 11/67 • Number of events 11 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	0.00% 0/67 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	1.5% 1/68 • Number of events 1 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	8.8% 6/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	16.4% 11/67 • Number of events 14 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	2.9% 2/68 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	9.0% 6/67 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	3.0% 2/67 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.8% 6/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	4.5% 3/67 • Number of events 3 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 2/68 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	7.5% 5/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Nervous system disorders Dizziness	2.9% 2/68 • Number of events 2 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	7.5% 5/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Nervous system disorders Headache	7.4% 5/68 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Psychiatric disorders Insomnia	5.9% 4/68 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	9.0% 6/67 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	10.3% 7/68 • Number of events 8 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	9.0% 6/67 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.1% 13/68 • Number of events 15 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	13.4% 9/67 • Number of events 10 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.4% 5/68 • Number of events 5 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	7.5% 5/67 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	10.3% 7/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	4.5% 3/67 • Number of events 3 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.4% 5/68 • Number of events 6 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	6.0% 4/67 • Number of events 4 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	11.8% 8/68 • Number of events 12 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	19.4% 13/67 • Number of events 13 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	8.8% 6/68 • Number of events 7 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	19.4% 13/67 • Number of events 14 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 1/68 • Number of events 1 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.	9.0% 6/67 • Number of events 8 • Up to primary completion date (approximately 11 months) The safety population included all participants who received at least one dose of study medication.