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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

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 below

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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:

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I have a serious heart condition.

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My NSCLC has a specific mutation in the EGFR gene or an ALK fusion.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

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

2016

Completed Phase 3

~5860

Tiragolumab

2019

Completed Phase 3

~2330