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

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ClinicalTrials.gov Identifier: NCT03563716
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Results First Posted : July 9, 2020
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Atezolizumab
Drug: Tiragolumab
Drug: Placebo
Enrollment 135
Recruitment Details Participants were recruited at study sites in 6 countries.
Pre-assignment Details 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.
Arm/Group Title Placebo + Atezolizumab Tiragolumab + Atezolizumab
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 68 67
Completed [1] 0 0 [2]
Not Completed 68 67
Reason Not Completed
Death             20             14
Withdrawal by Subject             3             3
Still on Study             45             50
[1]
Study still on-going
[2]
One participant who died had as reason for discontinuation "Withdrawal by Subject"
Arm/Group Title Placebo + Atezolizumab Tiragolumab + Atezolizumab Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 68 67 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 67 participants 135 participants
67.0  (9.9) 65.8  (10.4) 66.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Female
20
  29.4%
28
  41.8%
48
  35.6%
Male
48
  70.6%
39
  58.2%
87
  64.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Hispanic or Latino
0
   0.0%
1
   1.5%
1
   0.7%
Not Hispanic or Latino
63
  92.6%
60
  89.6%
123
  91.1%
Not Stated
5
   7.4%
4
   6.0%
9
   6.7%
Unknown
0
   0.0%
2
   3.0%
2
   1.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 67 participants 135 participants
Asian
23
  33.8%
18
  26.9%
41
  30.4%
White
40
  58.8%
42
  62.7%
82
  60.7%
Multiple
1
   1.5%
0
   0.0%
1
   0.7%
Unknown
4
   5.9%
7
  10.4%
11
   8.1%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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.
Time Frame From baseline until a total of 80 progression free survival (PFS) events have occurred (up to approximately 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all participants randomized in the study.
Arm/Group Title Placebo + Atezolizumab Tiragolumab + Atezolizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 68 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.2
(6.69 to 25.66)
31.3
(19.49 to 43.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Atezolizumab, Tiragolumab + Atezolizumab
Comments Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.57
Confidence Interval (2-Sided) 95%
1.07 to 6.14
Estimation Comments 95% CI for odds ratio was constructed using the Wald method.
2.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description 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).
Time Frame From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized in the study.
Arm/Group Title Placebo + Atezolizumab Tiragolumab + Atezolizumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 68 67
Median (95% Confidence Interval)
Unit of Measure: months
3.58
(2.73 to 4.44)
5.42 [1] 
(4.21 to NA)
[1]
95% Confidence Interval (CI) was not estimable as participants without documentation of progressive disease (PD) were censored.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Atezolizumab, Tiragolumab + Atezolizumab
Comments Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.37 to 0.90
Estimation Comments Hazard ratios were estimated by Cox regression.
3.Secondary Outcome
Title Duration of Objective Response (DOR)
Hide Description 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).
Time Frame Up to 6 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS, defined as the time from randomization to death from any cause.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description 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.
Time Frame Up to 6 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Serum Concentrations of Tiragolumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Serum Concentrations of Atezolizumab
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days)
Outcome Measure Data Not Reported
Time Frame Up to primary completion date (approximately 11 months)
Adverse Event Reporting Description The safety population included all participants who received at least one dose of study medication.
 
Arm/Group Title Placebo + Atezolizumab Tiragolumab + Atezolizumab
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo + Atezolizumab Tiragolumab + Atezolizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   20/68 (29.41%)      15/67 (22.39%)    
Hide Serious Adverse Events
Placebo + Atezolizumab Tiragolumab + Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/68 (35.29%)      23/67 (34.33%)    
Cardiac disorders     
Atrial fibrillation † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Cardio-respiratory arrest † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Myocarditis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Tachycardia † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Endocrine disorders     
Adrenal haemorrhage † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Colitis † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Constipation † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
General disorders     
Asthenia † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Multiple organ dysfunction syndrome † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Pain † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Pyrexia † 1  1/68 (1.47%)  1 1/67 (1.49%)  1
Hepatobiliary disorders     
Hepatitis † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Immune-mediated hepatitis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Infections and infestations     
Cytomegalovirus colitis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Epstein-Barr virus infection † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Influenza † 1  0/68 (0.00%)  0 2/67 (2.99%)  2
Lung infection † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Pleural infection bacterial † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Pneumonia † 1  4/68 (5.88%)  5 5/67 (7.46%)  5
Respiratory tract infection † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Skin infection † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Upper respiratory tract infection † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Urinary tract infection † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Injury, poisoning and procedural complications     
Infusion related reaction † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Investigations     
Alanine aminotransferase increased † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Aspartate aminotransferase increased † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Lipase increased † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Metabolism and nutrition disorders     
Decreased appetite † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Hyperglycaemia † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Hyponatraemia † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pericardial effusion malignant † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Nervous system disorders     
Cerebrovascular accident † 1  1/68 (1.47%)  2 0/67 (0.00%)  0
Encephalopathy † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Neurotoxicity † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Autoimmune nephritis † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Hydronephrosis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchospasm † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Dyspnoea † 1  1/68 (1.47%)  1 1/67 (1.49%)  1
Haemoptysis † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Interstitial lung disease † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Pleural effusion † 1  0/68 (0.00%)  0 4/67 (5.97%)  4
Pneumonia aspiration † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Pneumothorax † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Pulmonary embolism † 1  2/68 (2.94%)  2 0/67 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash maculo-papular † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Vascular disorders     
Pelvic venous thrombosis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
Phlebitis † 1  0/68 (0.00%)  0 1/67 (1.49%)  1
Vena cava thrombosis † 1  1/68 (1.47%)  1 0/67 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Atezolizumab Tiragolumab + Atezolizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/68 (85.29%)      60/67 (89.55%)    
Blood and lymphatic system disorders     
Anaemia † 1  4/68 (5.88%)  4 7/67 (10.45%)  7
Endocrine disorders     
Hypothyroidism † 1  4/68 (5.88%)  4 4/67 (5.97%)  4
Gastrointestinal disorders     
Abdominal pain † 1  3/68 (4.41%)  6 4/67 (5.97%)  5
Constipation † 1  9/68 (13.24%)  9 9/67 (13.43%)  9
Diarrhoea † 1  10/68 (14.71%)  11 9/67 (13.43%)  12
Nausea † 1  7/68 (10.29%)  9 4/67 (5.97%)  4
Vomiting † 1  6/68 (8.82%)  7 4/67 (5.97%)  5
General disorders     
Asthenia † 1  17/68 (25.00%)  18 17/67 (25.37%)  19
Fatigue † 1  9/68 (13.24%)  9 15/67 (22.39%)  18
Oedema peripheral † 1  3/68 (4.41%)  3 7/67 (10.45%)  10
Pyrexia † 1  9/68 (13.24%)  12 8/67 (11.94%)  9
Infections and infestations     
Respiratory tract infection † 1  5/68 (7.35%)  7 2/67 (2.99%)  2
Upper respiratory tract infection † 1  4/68 (5.88%)  4 5/67 (7.46%)  5
Injury, poisoning and procedural complications     
Infusion related reaction † 1  7/68 (10.29%)  17 18/67 (26.87%)  22
Investigations     
Alanine aminotransferase increased † 1  6/68 (8.82%)  6 3/67 (4.48%)  3
Amylase increased † 1  2/68 (2.94%)  2 4/67 (5.97%)  9
Aspartate aminotransferase increased † 1  5/68 (7.35%)  5 5/67 (7.46%)  5
Blood creatinine increased † 1  4/68 (5.88%)  4 1/67 (1.49%)  2
Lipase increased † 1  2/68 (2.94%)  2 4/67 (5.97%)  7
Weight decreased † 1  3/68 (4.41%)  3 4/67 (5.97%)  4
Metabolism and nutrition disorders     
Decreased appetite † 1  12/68 (17.65%)  12 11/67 (16.42%)  11
Hypercalcaemia † 1  4/68 (5.88%)  4 0/67 (0.00%)  0
Hypokalaemia † 1  1/68 (1.47%)  1 4/67 (5.97%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  6/68 (8.82%)  7 11/67 (16.42%)  14
Back pain † 1  2/68 (2.94%)  2 6/67 (8.96%)  6
Musculoskeletal chest pain † 1  4/68 (5.88%)  4 2/67 (2.99%)  2
Musculoskeletal pain † 1  6/68 (8.82%)  7 4/67 (5.97%)  4
Myalgia † 1  4/68 (5.88%)  4 3/67 (4.48%)  3
Pain in extremity † 1  2/68 (2.94%)  2 5/67 (7.46%)  5
Nervous system disorders     
Dizziness † 1  2/68 (2.94%)  2 5/67 (7.46%)  5
Headache † 1  5/68 (7.35%)  5 4/67 (5.97%)  5
Psychiatric disorders     
Insomnia † 1  4/68 (5.88%)  4 6/67 (8.96%)  6
Respiratory, thoracic and mediastinal disorders     
Cough † 1  7/68 (10.29%)  8 6/67 (8.96%)  6
Dyspnoea † 1  13/68 (19.12%)  15 9/67 (13.43%)  10
Haemoptysis † 1  5/68 (7.35%)  5 5/67 (7.46%)  6
Productive cough † 1  7/68 (10.29%)  7 3/67 (4.48%)  3
Rhinorrhoea † 1  5/68 (7.35%)  6 4/67 (5.97%)  4
Skin and subcutaneous tissue disorders     
Pruritus † 1  8/68 (11.76%)  12 13/67 (19.40%)  13
Rash † 1  6/68 (8.82%)  7 13/67 (19.40%)  14
Rash maculo-papular † 1  1/68 (1.47%)  1 6/67 (8.96%)  8
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03563716    
Other Study ID Numbers: GO40290
2018-000280-81 ( EudraCT Number )
First Submitted: April 17, 2018
First Posted: June 20, 2018
Results First Submitted: June 19, 2020
Results First Posted: July 9, 2020
Last Update Posted: April 30, 2024