261 Participants Needed

Selpercatinib for Advanced Non-Small Cell Lung Cancer

(LIBRETTO-431 Trial)

Recruiting at 348 trial locations
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Overseen ByThere will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic steroid treatment, you may not be eligible to participate.

Is selpercatinib safe for humans?

Selpercatinib, also known as RETEVMO, has been shown to have an acceptable safety profile in clinical trials for advanced non-small cell lung cancer. Most side effects were manageable with dose adjustments, and only a few patients stopped treatment due to side effects. Common serious side effects included high blood pressure and elevated liver enzymes.12345

How is the drug Selpercatinib unique for treating advanced non-small cell lung cancer?

Selpercatinib is unique because it is an oral medication specifically designed to target and inhibit the RET kinase, which is involved in certain genetic alterations in non-small cell lung cancer. It has shown strong and lasting responses, even in patients who have already undergone other treatments, and is effective in treating cancer that has spread to the brain.12367

What data supports the effectiveness of the drug Selpercatinib for advanced non-small cell lung cancer?

Research shows that Selpercatinib is effective in treating advanced non-small cell lung cancer with RET fusion, leading to strong and lasting responses, even in patients with brain metastases. It has been approved by the FDA for this use based on positive results from clinical trials, demonstrating its promise as a new treatment option.12358

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.
See 3 more

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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Selpercatinib or a combination of Pemetrexed and Platinum with or without Pembrolizumab

Up to 31 months

Crossover

Participants on standard treatment may crossover to Selpercatinib upon disease progression

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 38 months

What Are the Treatments Tested in This Trial?

Interventions

  • Selpercatinib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Selpercatinib - Treatment A (TRT A)Experimental Treatment1 Intervention
Group II: Pemetrexed and Platinum with or without Pembrolizumab - (TRT B)Active Control4 Interventions

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

🇺🇸
Approved in United States as RETEVMO for:
🇪🇺
Approved in European Union as RETEVMO for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials
72
Recruited
11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Published Research Related to This Trial

Selpercatinib (RETEVMO™) is a targeted therapy that inhibits the RET receptor tyrosine kinase, specifically designed for cancers with RET alterations.
It received FDA approval based on the promising results from the phase I/II LIBRETTO-001 trial for treating RET fusion-positive non-small-cell lung cancer, RET fusion-positive thyroid cancer, and RET-mutant medullary thyroid cancer.
Selpercatinib: First Approval.Markham, A.[2021]
Selpercatinib is an effective oral treatment for advanced RET fusion-positive non-small cell lung cancer (NSCLC), showing strong and lasting responses in both previously treated and treatment-naïve patients during a pivotal phase 1/2 clinical trial.
The drug has a manageable safety profile, with most adverse events being manageable through dose adjustments, and only a small number of patients discontinuing treatment due to side effects, which primarily included hypertension and elevated liver enzymes.
Selpercatinib: A Review in Advanced RET Fusion-Positive NSCLC.Nie, T., Syed, YY.[2023]
Selpercatinib showed a high objective response rate (ORR) of 84% in treatment-naive patients and 61% in those previously treated with platinum-based chemotherapy, indicating its efficacy in RET fusion-positive non-small-cell lung cancer (NSCLC).
The treatment demonstrated durable responses, with a median duration of response (DoR) of 20.2 months for treatment-naive patients and 28.6 months for those pretreated, along with a significant intracranial ORR of 85% in patients with CNS metastasis.
Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial.Drilon, A., Subbiah, V., Gautschi, O., et al.[2023]

Citations

Selpercatinib: First Approval. [2021]
Selpercatinib: A Review in Advanced RET Fusion-Positive NSCLC. [2023]
Selpercatinib in Patients With RET Fusion-Positive Non-Small-Cell Lung Cancer: Updated Safety and Efficacy From the Registrational LIBRETTO-001 Phase I/II Trial. [2023]
Intracranial Activity of Selpercatinib in Chinese Patients With Advanced RET Fusion-Positive Non-Small-Cell Lung Cancer in the Phase II LIBRETTO-321 Trial. [2023]
External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. [2022]
Hypersensitivity Reactions to Selpercatinib Treatment With or Without Prior Immune Checkpoint Inhibitor Therapy in Patients With NSCLC in LIBRETTO-001. [2022]
Selpercatinib in RET-fusion positive metastatic non-small cell lung cancer: achievements and gray areas. [2022]
[Efficacy and Safety Analysis of Selpercatinib in Patients with RET Fusion-Positive Non-Small Cell Lung Cancer-Results from the Japanese Subset of a Global Phase 1/2 Study]. [2022]
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