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Monoclonal Antibodies

GDC-1971 + Osimertinib/Cetuximab for Non-Small Cell Lung Cancer

Phase 1

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 confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)

Negative for acquired on-target EGFR alterations

Must not have

History of pulmonary firbrosis, organizing pneumonia, or pneumonitis

Leptomeningeal disease or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety of a drug (GDC-1971) when used with other treatments for cancer. It tests different doses and looks at effects.

Who is the study for?

This trial is for adults with certain types of advanced lung or colorectal cancer. Participants must have specific genetic mutations, good organ function, and a performance status indicating they can care for themselves. They should not have had recent major surgeries or treatments, no active infections like hepatitis or HIV, and no history of significant heart, liver, or eye disease.

What is being tested?

The study tests the safety and effectiveness of GDC-1971 when combined with Osimertinib for lung cancer patients or Cetuximab for colorectal cancer patients. It includes an initial phase to find the right dose followed by a phase to see how well it works at that dose.

What are the potential side effects?

Potential side effects may include typical reactions from targeted cancer therapies such as skin rash, diarrhea, abnormal liver blood tests, fatigue and allergic reactions. The exact side effects will be monitored closely given this is a safety-focused study.

Eligibility Criteria

Inclusion Criteria

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

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My colon or rectum cancer has worsened after treatment with an EGFR inhibitor.

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My cancer does not have EGFR mutations.

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I am fully active or can carry out light work.

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My cancer does not have KRAS gene changes.

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My cancer does not have the BRAF V600E mutation.

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My cancer has a specific EGFR mutation.

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My cancer does not have NRAS gene changes.

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My lung cancer has worsened after treatment with a specific lung cancer medication.

Exclusion Criteria

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

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I have had pulmonary fibrosis, organizing pneumonia, or pneumonitis.

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My cancer has spread to the lining of my brain or spinal cord.

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I have untreated or active brain metastases needing medication for symptoms.

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I am HIV positive.

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I do not have conditions affecting my body's ability to absorb nutrients.

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I have difficulty with blood draws or IV insertions due to poor vein access.

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I have high calcium levels in my blood that aren't managed.

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I have a history of eye disease.

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I have a history of serious heart problems.

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I have a significant history of liver problems.

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I have not had a serious infection in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment2 Interventions

Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at an assigned dose, orally, once daily (QD), on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 milligrams (mg), orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.

Group II: Dose-Finding Stage: Colorectal Cancer (CRC)Experimental Treatment2 Interventions

Participants with metastatic CRC will receive GDC-1971, at an assigned dose, orally, QD, on Days 1 to 28 days of each 28-day cycle in combination with cetuximab, 500 milligrams per square meter (mg/m\^2), given by IV infusion on Days 1 and 15 of each cycle, until disease progression or unacceptable toxicity.

Group III: Dose Expansion Stage: NSCLCExperimental Treatment2 Interventions

Participants with unresectable, locally advanced or metastatic NSCLC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with osimertinib, 80 mg, orally, QD, on Days 1 to 28 of each cycle until disease progression or unacceptable toxicity.

Group IV: Dose Expansion Stage: CRCExperimental Treatment2 Interventions

Participants with metastatic CRC will receive GDC-1971 at a dose determined in the dose finding stage, orally, QD, on Days 1 to 28 of each 28-day cycle in combination with cetuximab, 500 mg/m\^2, given by IV infusion on Days 1 and 15 of each cycle until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1100

Cetuximab

2011

Completed Phase 3

~2480