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PD-L1 Inhibitor

Atezolizumab + Cobimetinib for Lung Cancer

Phase 2

Waitlist Available

Led By Stephen V Liu

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (any histology is permitted)

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam

Must not have

Uncontrolled pleural or pericardial effusion or ascites requiring recurrent drainage procedures

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of atezolizumab and cobimetinib to treat patients with non-small cell lung cancer.

Who is the study for?

Adults with metastatic, recurrent, or treatment-resistant non-small cell lung cancer who have previously not responded well to anti-PD-1/PD-L1 therapy. Participants must be over 18, have measurable disease, and acceptable organ function. Those with certain gene mutations may join specific cohorts. Pregnant women and individuals with uncontrolled diseases or recent significant adverse events from cancer therapies are excluded.

What is being tested?

The trial is testing the combination of atezolizumab (an immunotherapy drug) and cobimetinib (a kinase inhibitor for cancers with a mutated BRAF gene) in patients whose lung cancer has spread or resisted previous treatments. The study aims to see if this drug combo is more effective than current standard care.

What are the potential side effects?

Potential side effects include immune-related reactions that can affect organs, fatigue, liver issues, digestive problems like diarrhea and nausea, skin rash, hormonal gland problems leading to hormone imbalances, muscle pain or weakness.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is confirmed to be metastatic or recurrent through testing.

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I have a tumor that can be measured with imaging or physical exam.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My kidneys are working well enough (creatinine clearance >= 30).

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I am willing to have a biopsy for research purposes.

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My cancer does not have a KRAS mutation.

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My cancer has a KRAS mutation as confirmed by a specific test.

Exclusion Criteria

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

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I frequently need procedures to remove fluid from my chest or abdomen.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I do not have a history of long QT syndrome and my heart's QT interval is normal.

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I have not had a serious infection needing treatment in the last 2 weeks.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I do not have symptoms from cancer spread to my brain.

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I have not had severe bleeding in the last 4 weeks.

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I do not have any serious illnesses that would stop me from following the study's requirements.

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I have a history of serious eye conditions that could affect my retina.

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I have or am at risk for an autoimmune disease.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I have a condition that affects how my body absorbs food.

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I am not pregnant or breastfeeding.

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I have not received a live vaccine in the last 4 weeks and won't need one during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Biomarker analysis

Grade 3 and 4 toxicities

Overall response rate

+2 more

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: Treatment (atezolizumab, cobimetinib)Experimental Treatment6 Interventions

Patients receive atezolizumab IV over 30-60 minutes on days 1, and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Patients also undergo a CT scan, MRI, biopsy, and collection of blood throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Biospecimen Collection

2004

Completed Phase 3

~2030