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Monoclonal Antibodies
Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Must not have
Significant cardiovascular disease
Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Summary
This trial will test a new combo drug to see if it's more effective than current treatment for a certain type of lung cancer.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that hasn't been treated with chemotherapy. Participants must have tumors expressing PD-L1, a life expectancy of at least 12 weeks, and good organ function. They should not be pregnant or breastfeeding, agree to use contraception, and have no history of certain diseases like autoimmune disorders or severe allergies to specific antibodies.
What is being tested?
The study tests the combination of two drugs: Tiragolumab and Atezolizumab versus a placebo plus Atezolizumab in patients who haven't had chemo before. It aims to see if adding Tiragolumab improves outcomes in NSCLC patients selected based on PD-L1 expression.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue, potential liver issues, and an increased risk of infections due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.
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I agree to either not have sex or use birth control, and not donate sperm.
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I am fully active or can carry out light work.
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I haven't had any systemic treatment for my advanced lung cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious heart condition.
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My NSCLC has a specific mutation in the EGFR gene or an ALK fusion.
Select...
I have had leptomeningeal disease.
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I frequently need procedures to remove excess fluid from my chest or abdomen.
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I have pain from my cancer that isn't relieved by treatment.
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I have high calcium levels that need ongoing treatment.
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I have a history of lung scarring or inflammation not caused by infections.
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I haven't had major surgery in the last 4 weeks.
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I have not received a live vaccine in the last 4 weeks.
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I have brain metastases that are untreated or getting worse.
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I have had a bone marrow or organ transplant in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Secondary study objectives
Duration of Objective Response (DOR)
Overall Survival (OS)
Percentage of Participants With Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tiragolumab + AtezolizumabExperimental Treatment2 Interventions
Participants will receive 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 tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Group II: Placebo + AtezolizumabPlacebo Group2 Interventions
Participants will receive 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5850
Tiragolumab
2019
Completed Phase 3
~1400
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,550 Previous Clinical Trials
568,229 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,281 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I have not had a severe infection in the last 4 weeks.My lung cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.You have a positive test for HIV, active hepatitis B or C, or active tuberculosis.My blood and organs are functioning well.I agree to either not have sex or use birth control, and not donate sperm.My NSCLC has a specific mutation in the EGFR gene or an ALK fusion.My spinal cord compression hasn't been treated or stabilized for 2 weeks.I have had leptomeningeal disease.I frequently need procedures to remove excess fluid from my chest or abdomen.I haven't had any cancer other than NSCLC in the last 5 years, or if I did, it was not serious and was treated.I have a history of lung scarring or inflammation not caused by infections.I have high calcium levels that need ongoing treatment.I have pain from my cancer that isn't relieved by treatment.The level of PD-L1 in the tumor.I haven't had major surgery in the last 4 weeks.You are expected to live for at least 12 more weeks.I am fully active or can carry out light work.I have not received a live vaccine in the last 4 weeks.You have a disease that can be measured using a specific set of guidelines.I have brain metastases that are untreated or getting worse.I haven't had any systemic treatment for my advanced lung cancer.You have had an autoimmune disease in the past.You have had serious allergic reactions to certain types of medications made from animals or cells, or have allergies to specific components of atezolizumab.I have had a bone marrow or organ transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Atezolizumab
- Group 2: Tiragolumab + Atezolizumab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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