Trametinib + Docetaxel for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+693 other locations

Overseen byShirish M Gadgeel

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.

Research Team

Shirish M Gadgeel

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that has a specific KRAS mutation. Participants must not have brain metastases unless treated and stable, no recent chemotherapy or investigational drugs, normal organ function tests, no history of significant heart disease or interstitial lung disease, and cannot be pregnant. They should not have had certain prior treatments like MEK inhibitors.

Inclusion Criteria

I've had radiation that didn't affect more than 25% of my bone marrow and have recovered from its side effects.

I am not taking any herbal supplements.

Your hemoglobin level is at least 9 grams/dl, and this was checked within the last 28 days before joining the study.

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Treatment Details

Interventions

Docetaxel (Taxane)
Trametinib (MEK Inhibitor)

Trial OverviewThe study is testing the combination of trametinib, which blocks enzymes needed for tumor growth, and docetaxel, a chemotherapy drug that kills or stops cancer cells from dividing. The goal is to see if this combo works better than current treatments for NSCLC with KRAS mutations.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (trametinib, docetaxel)Experimental Treatment3 Interventions

Patients receive trametinib PO on days 1-21. Patients also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Docetaxel is already approved in Canada, Japan for the following indications: