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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 belowSelect...
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:Select...
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
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
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,554 Previous Clinical Trials
568,770 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,217 Previous Clinical Trials
894,679 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Dose-Finding Stage: Non-Small Cell Lung Cancer (NSCLC)
- Group 2: Dose-Finding Stage: Colorectal Cancer (CRC)
- Group 3: Dose Expansion Stage: NSCLC
- Group 4: Dose Expansion Stage: CRC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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