Selpercatinib for Advanced Non-Small Cell Lung Cancer
(LIBRETTO-431 Trial)

Recruiting in Palo Alto (17 mi)

+348 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Eligibility Criteria

This trial is for adults with advanced non-squamous NSCLC that has spread and have a RET gene fusion. They must be in fairly good health, able to take pills, and not had certain treatments for metastatic disease. Women can't be pregnant or breastfeeding, and participants need effective birth control.

Inclusion Criteria

My cancer has a RET gene mutation.

I can take care of myself and am up and about more than half of my waking hours.

My blood, liver, and kidney functions are all within normal ranges.

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Exclusion Criteria

I have no active cancer except for certain skin cancers, cervical pre-cancers, or any cancer that was treated over 2 years ago and is not currently active.

I haven't had radiotherapy for symptom relief within a week or high-dose lung radiotherapy in the last 6 months.

I need to take steroids regularly for my condition.

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Treatment Details

Interventions

Selpercatinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe study tests Selpercatinib against standard treatments (Pemetrexed, Pembrolizumab, Carboplatin, Cisplatin) for NSCLC with RET fusion. If standard treatment fails, patients may switch to Selpercatinib. The goal is to compare effectiveness and safety.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Selpercatinib - Treatment A (TRT A)Experimental Treatment1 Intervention

160 milligram (mg) Selpercatinib administered orally twice daily (BID) continuously in 21-day cycles.

Group II: Pemetrexed and Platinum with or without Pembrolizumab - (TRT B)Active Control4 Interventions

Pemetrexed 500 milligrams per meter squared (mg/m2) administered intravenously (IV) on Day 1, every 3 weeks (Q3W), plus investigator's choice of carboplatin area under the concentration versus time curve 5 (AUC 5 \[maximum dose of 750 mg\] IV), or cisplatin (75 mg/m2 cisplatin IV) on Day 1 Q3W for 4 cycles, plus investigator's choice with or without 200 mg pembrolizumab IV on Day 1 Q3W up to 35 cycles.

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

🇺🇸 Approved in United States as RETEVMO for: