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Tyrosine Kinase Inhibitor

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

Phase 3
Waitlist Available
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of a RET gene fusion in tumor and/or blood from a qualified laboratory.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Must not have
Requiring chronic treatment with steroids.
Uncontrolled, disease related pericardial effusion or pleural effusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death from any cause up to 38 months
Awards & highlights

Summary

This trial is testing a new drug for people with a certain type of lung cancer that has spread to other parts of the body. The new drug is compared to the standard treatment, and participants who stop the standard treatment due to their cancer progressing can try the new drug.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Selpercatinib may cause liver issues, high blood pressure, bleeding problems; Pemetrexed can lead to fatigue or skin reactions; Pembrolizumab might trigger immune system-related side effects; Carboplatin/Cisplatin could cause kidney damage or hearing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a RET gene mutation.
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I can take care of myself and am up and about more than half of my waking hours.
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My non-squamous NSCLC is at Stage IIIB-IIIC or IV and cannot be treated with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need to take steroids regularly for my condition.
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I have fluid buildup around my heart or lungs that isn't managed.
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I do not have an active autoimmune disease or a condition that weakens my immune system.
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I have not had major surgery in the last 3 weeks.
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I do not have a condition that affects how my body absorbs medication.
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I have never had interstitial lung disease or pneumonitis.
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I have symptoms from cancer spread to my brain or spinal cord.
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I do not have any uncontrolled infections or serious illnesses like high blood pressure or diabetes.
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My lung cancer has other known genetic changes.
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I haven't had a heart attack or significant heart disease in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of death from any cause up to 38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death from any cause up to 38 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PFS by BICR (With or Without Pembrolizumab)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab)
Secondary study objectives
DOR by BICR (With or Without Pembrolizumab)
Duration of Response (DoR) by BICR (With Pembrolizumab)
Intracranial DOR Per RANO-BM by BICR (With Pembrolizumab)
+20 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selpercatinib
2021
Completed Phase 1
~600

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
69 Previous Clinical Trials
10,041 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,383 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,829 Total Patients Enrolled

Media Library

Selpercatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04194944 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Pemetrexed and Platinum with or without Pembrolizumab - (TRT B), Selpercatinib - Treatment A (TRT A)
Non-Small Cell Lung Cancer Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT04194944 — Phase 3
Selpercatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04194944 — Phase 3
~47 spots leftby Sep 2025
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