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Monoclonal Antibodies

Tiragolumab + Atezolizumab + Bevacizumab for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Joshua Reuss, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at time of signing ICF

Confirmed activating alteration in EGFR (cohort B only)

Must not have

Inadequately controlled hypertension

Any other condition contraindicating the use of an investigational drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of treatment (average 9 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether combining tiragolumab with atezolizumab and bevacizumab is more effective than atezolizumab and bevacizumab alone in treating advanced non-squamous NSCLC.

Who is the study for?

Adults with advanced non-squamous NSCLC that's progressed after treatment can join. They must have a certain level of PD-L1 expression, not be pregnant or breastfeeding, and agree to use contraception. People with severe heart disease, recent infections, prior TIGIT therapy, or uncontrolled hypertension are excluded.

What is being tested?

The trial tests Tiragolumab combined with Atezolizumab and Bevacizumab in patients whose NSCLC has worsened despite previous treatments. It aims to assess the effectiveness of this combination therapy.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, bleeding issues due to Bevacizumab's effect on blood vessels, fatigue, liver function changes from Atezolizumab and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer has a specific EGFR mutation.

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My cancer does not have mutations in EGFR, ALK, or ROS1 genes.

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My advanced lung cancer cannot be treated with surgery or radiation.

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I agree to use birth control or remain abstinent.

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My biopsy after treatment failure shows non-squamous cell type.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not well controlled.

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I do not have any health issues that prevent me from taking experimental medications.

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I stopped immunotherapy permanently due to severe side effects.

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I have previously received anti-TIGIT antibody therapy.

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I have a serious wound, ulcer, or untreated bone fracture that is not healing.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have a history of serious heart or blood vessel problems.

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I have a history of gastrointestinal issues.

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I have a history of serious bleeding or blood clotting issues.

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I have had lung conditions or infections before.

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I have had a previous transplant of stem cells or an organ.

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I have not had major surgery in the last 4 weeks.

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I have brain metastases that are either untreated or causing symptoms.

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I am currently taking or have recently taken specific medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of treatment (average 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of treatment (average 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of treatment (average 9 months) 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)

Secondary study objectives

Incidence of Treatment-Related Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tiragolumab plus atezolizumab and bevacizumabExperimental Treatment3 Interventions

Tiragolumab 600mg IV will be administered together with atezolizumab 1200mg IV and bevacizumab 15mg/kg IV every 3 weeks (q3w) until progressive disease or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

2019

Completed Phase 3

~2330

Atezolizumab

2016

Completed Phase 3

~5860