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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death from any cause (estimated at up to 48 months)
Awards & highlights
LIBRETTO-431 Trial 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.Check my eligibility
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.See study design
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.
LIBRETTO-431 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a RET gene mutation.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My non-squamous NSCLC is at Stage IIIB-IIIC or IV and cannot be treated with surgery or radiation.
LIBRETTO-431 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to date of death from any cause (estimated at up to 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of death from any cause (estimated at up to 48 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS by BICR (with or without Pembrolizumab)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab)
Secondary outcome measures
DCR by BICR (with or without Pembrolizumab)
DOR by BICR (with or without Pembrolizumab)
Disease Control Rate (DCR) by BICR (with Pembrolizumab)
+20 moreLIBRETTO-431 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 Patinum 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 at the 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
66 Previous Clinical Trials
9,608 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,299 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,493 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have an active autoimmune disease or a condition that weakens my immune system.My cancer has a RET gene mutation.I have not had major surgery in the last 3 weeks.I do not have a condition that affects how my body absorbs medication.I can take care of myself and am up and about more than half of my waking hours.I have fluid buildup around my heart or lungs that isn't managed.My blood, liver, and kidney functions are all within normal ranges.I agree to use effective birth control during and for 6 months after treatment.I have never had interstitial lung disease or pneumonitis.I had treatment for cancer that spread, but finished any early treatments over 6 months ago.I have symptoms from cancer spread to my brain or spinal cord.I do not have any uncontrolled infections or serious illnesses like high blood pressure or diabetes.My non-squamous NSCLC is at Stage IIIB-IIIC or IV and cannot be treated with surgery or radiation.My lung cancer has other known genetic changes.I haven't had a heart attack or significant heart disease in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Selpercatinib - Treatment A (TRT A)
- Group 2: Pemetrexed and Patinum with or without Pembrolizumab - (TRT B)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the key benefits of Selpercatinib?
"Selpercatinib is an effective treatment for malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
What are the long-term risks associated with Selpercatinib use?
"Selpercatinib's safety has been backed by multiple clinical trials, giving it a score of 3."
Answered by AI
Can new patients enroll in this research project?
"From what is published on clinicaltrials.gov, this clinical trial is still recruiting patients. The initial posting was on February 17th, 2020 with the most recent edit on October 19th, 2020."
Answered by AI
Are there any previous findings from research involving Selpercatinib?
"As of right now, there are 2053 clinical trials underway that are studying Selpercatinib. 472 of those trials are currently in Phase 3. The majority of the trials for Selpercatinib are based in Shanghai, but there are 89920 locations worldwide where trials for this treatment are taking place."
Answered by AI
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