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Selpercatinib for Non-Small Cell Lung Cancer (LIBRETTO-432 Trial)

Phase 3

Recruiting

Research Sponsored by Loxo Oncology, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Maximum time allowed between definitive therapy completion and randomization must be: 10 weeks if no chemotherapy was administered, 26 weeks if adjuvant chemotherapy was administered.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to death from any cause (estimated as up to 9 years)]

Awards & highlights

LIBRETTO-432 Trial Summary

This trial is testing a new drug to see if it can prevent cancer from returning in people who have had surgery or radiation for early-stage lung cancer. It will last up to three years, and people whose cancer comes back while taking the placebo will be able to switch to the new drug.

Who is the study for?

This trial is for people with early-stage non-small cell lung cancer who've had surgery or radiation. They must be in good physical condition, have proper organ function, and a specific RET gene change in their tumor. Participants should not have used certain other cancer drugs before, nor should they have serious illnesses like uncontrolled infections or heart problems.Check my eligibility

What is being tested?

The study tests if Selpercatinib can prevent cancer from returning compared to a placebo in patients with NSCLC post-surgery or radiation. If the disease worsens on placebo, those participants might switch to Selpercatinib. The trial could last up to three years.See study design

What are the potential side effects?

While the side effects of Selpercatinib are not detailed here, similar medications often cause issues like liver enzyme changes, high blood pressure, dry mouth, diarrhea, fatigue and possibly affect heart rhythm.

LIBRETTO-432 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I finished my main cancer treatment less than 10 weeks ago without chemotherapy, or less than 26 weeks ago with chemotherapy.

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I had surgery or radiotherapy for early-stage lung cancer.

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My tumor has an activating RET gene fusion confirmed by a test.

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My lung cancer is confirmed to be at Stage IB, II, or IIIA.

LIBRETTO-432 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to death from any cause (estimated as up to 9 years)]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to death from any cause (estimated as up to 9 years)]

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to death from any cause (estimated as up to 9 years)] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-Free Survival (EFS)

Secondary outcome measures

EFS

Mean Change from Baseline over Time in NSCLC Symptoms

Mean Change from Baseline over Time in Physical Function

+4 more

LIBRETTO-432 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SelpercatinibExperimental Treatment1 Intervention

Selpercatinib administered orally.

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selpercatinib

2021

Completed Phase 1

~600

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,429 Total Patients Enrolled

Loxo Oncology, Inc.Lead Sponsor

66 Previous Clinical Trials

9,699 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,575 Total Patients Enrolled

Media Library

Selpercatinib Clinical Trial Eligibility Overview. Trial Name: NCT04819100 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Selpercatinib, Placebo

Non-Small Cell Lung Cancer Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT04819100 — Phase 3

Selpercatinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04819100 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the normal indications for Selpercatinib?

"Selpercatinib is frequently given to patients with medullary carcinoma of thyroid. Other conditions that this medication can ameliorate include adrenal medulla, radioactive iodine-refractory, and require systemic therapy."

Answered by AI

Are there any other treatments that have been studied alongside Selpercatinib?

"Selpercatinib was first trialed in 2017 at the Severance Hospital. Since then, 18301 have completed clinical trials across the globe. There are 11 active trials as of now, with a significant portion taking place in Toronto, Canada."

Answered by AI

What are the precedents for this research?

"Selpercatinib has been under investigation since 2017 by Eli Lilly and Company. The first study, involving 875 participants, occurred in that year. Selpercatinib received Phase 1 & 2 approval after the successful trial. There are currently 11 active studies for Selpercatinib taking place in 584 cities across 34 countries."

Answered by AI

Are we able to sign new participants up for this experiment?

"Yes, according to the latest information on clinicaltrials.gov, this trial is looking for 170 patients at 22 different sites. The posting date was December 20th, 2021 and the most recent update was November 10th, 2022."

Answered by AI

Has the U.S. Food and Drug Administration okayed Selpercatinib?

"Selpercatinib's safety was given a score of 3 by our analysts. This is due to the fact that Selpercatinib has reached Phase 3 in clinical trials, so there is both efficacy and safety data available."

Answered by AI

How many different medical clinics are running this trial today?

"22 hospitals and medical research institutes are currently taking part in this study. These include locations in Toronto, Clifton Park, Boston as well as other cities. If you enroll, try to select the site that is closest to your residence to reduce travel time and expenses."

Answered by AI

How many people are currently enrolled in this clinical trial?

"One hundred and seventy patients that meet the necessary requirements are required for this clinical trial. The sponsor, Eli Lilly and Company, will be managing the study from multiple locations including Princess Margaret Hospital in Toronto, Ontario and New york Oncology Hematology, P.C in Clifton Park, Massachusetts."

Answered by AI

Recent research and studies

retJournal

LIBRETTO-432, a Phase III Study of Adjuvant Selpercatinib or Placebo in Stage IB-IIIA <i>ret</i> Fusion-positive Non-small-cell Lung Cancer

Tsuboi, Masahiro, Jonathan W Goldman, Yi-Long Wu, Melissa L Johnson, Luis Paz-Ares, James Chih-Hsin Yang, Benjamin Besse, Weiji Su, Bo H Chao, and Alexander Drilon. 2022. “LIBRETTO-432, a Phase III Study of Adjuvant Selpercatinib or Placebo in Stage IB-IIIA ret Fusion-positive Non-small-cell Lung Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0656.

clinicaltrials.govStudy

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

2021. "A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04819100.

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