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Kinase Inhibitor

Targeted Drug Therapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Sarah B Goldberg

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

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

Must have

Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable

Participants must have recovered (=< grade 1) from any side effects of prior therapy, except for alopecia and vitiligo

Must not have

Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization

Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests targeted drugs to treat advanced non-small cell lung cancer with gene changes, to help stop or slow the spread of cancer cells and shrink tumors.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has spread and contains specific gene changes (EGFR and MET). Participants must have progressed on osimertinib treatment, be able to swallow pills, have adequate organ function, not be pregnant or breastfeeding, agree to use contraception if of reproductive potential, and not have certain medical conditions or treatments that could interfere with the study.

What is being tested?

The trial tests a combination of targeted drugs: capmatinib (a kinase inhibitor), osimertinib (another kinase inhibitor), and ramucirumab (a monoclonal antibody). These drugs aim to block proteins signaling cancer cells to multiply and prevent tumor growth by stopping new blood vessels from forming. The effectiveness in shrinking or stabilizing lung cancer will be studied.

What are the potential side effects?

Potential side effects include high blood pressure due to ramucirumab; diarrhea, rash, dry skin from osimertinib; fatigue; liver enzyme changes; possible heart rhythm problems. Side effects vary based on individual responses to the medication.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be seen or measured on a scan taken recently.

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I have recovered from previous treatment side effects, except for hair loss or skin color loss.

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My blood tests for pancreas enzymes are normal and I show no signs of pancreas problems.

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I have HIV, am on effective treatment, and my viral load has been undetectable for the last 6 months.

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My heart is healthy enough for the trial, meeting the NYHA class 2B or better.

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My liver function tests are within the required range.

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I can swallow pills without any difficulty.

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My lung cancer has a specific mutation and has worsened despite treatment with osimertinib.

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My recent urine test shows normal or slightly elevated protein levels.

Exclusion Criteria

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

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I haven't taken any cancer drugs (except osimertinib) in the last 21 days.

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I am not planning to receive any other cancer treatments while on this study.

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I have not taken drugs targeting VEGF or MET for my condition.

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My blood pressure has been stable for the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Investigator-assessed progression-free survival

Secondary study objectives

Dose limiting toxicity (DLT)

Duration of response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (capmatinib, osimertinib)Experimental Treatment5 Interventions

Patients receive capmatinib PO and osimertinib PO on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.

Group II: Arm A (capmatinib, osimertinib, ramucirumab)Experimental Treatment6 Interventions

Patients receive capmatinib PO, osimertinib PO, and ramucirumab IV on study. Patients also undergo CT scan or MRI and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Capmatinib

2021

Completed Phase 3

~570