Targeted Therapy with Selpercatinib for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+264 other locations

Overseen byYasir Y Elamin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II Lung-MAP treatment trial tests whether carboplatin and pemetrexed with or without selpercatinib works to shrink tumors in patients with RET fusion-positive non-small cell lung cancer that is stage IV or has not responded to previous RET directed therapy. Chemotherapy drugs, such as carboplatin and pemetrexed, 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. Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib in combination with carboplatin and pemetrexed may help lower the chance of the cancer growing and spreading.

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer that's RET fusion-positive and either stage IV or resistant to previous RET therapy. They must be able to swallow pills, have no major surgeries within the last 14 days, not be pregnant/nursing, and agree to use contraception. Excluded are those with certain heart diseases, untreated brain metastases, or other cancers that could affect the trial's safety or results.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My condition worsened after treatment with anti-RET inhibitors.

I have had a physical exam within the last 28 days.

+11 more

Exclusion Criteria

I do not have another cancer that could affect this treatment's safety or results.

I have not had any major surgery in the last 14 days.

Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process

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Participant Groups

The study tests if adding Selpercatinib (a targeted drug blocking enzymes for cell growth) to chemotherapy drugs Carboplatin and Pemetrexed can shrink tumors better in patients with specific genetic changes in their lung cancer cells. It's a phase II trial where some participants will receive this combination treatment while others won't.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (carboplatin, pemetrexed, selpercatinib)Experimental Treatment3 Interventions

Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (carboplatin, pemetrexed)Active Control2 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: