What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include RET kinase inhibitors such as selpercatinib. The known side effects of selpercatinib include hypertension, increased aspartate aminotransferase levels, hyponatremia, and lymphopenia. Severe adverse events, although less common, can include sepsis, cardiac arrest, multiple organ dysfunction syndrome, pneumonia, and respiratory failure. These treatments can also cause other side effects like fatigue, diarrhea, and dry mouth. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Non-Small Cell Lung Cancer (NSCLC). Selpercatinib, a RET kinase inhibitor, received accelerated approval on May 8, 2020, for adult patients with metastatic RET fusion-positive NSCLC. Other targeted therapies include erlotinib, approved for patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Additionally, other RET inhibitors like pralsetinib have also been approved for RET fusion-positive NSCLC. These approvals highlight the shift towards personalized, genotype-directed therapies in the treatment of NSCLC.

What other types of research exist?

Promising alternatives to Selpercatinib for NSCLC patients include Pralsetinib, another RET inhibitor that has shown effectiveness in treating RET fusion-positive NSCLC and brain metastases. Additionally, other targeted therapies such as Alectinib, Crizotinib, Entrectinib, Ceritinib, Lorlatinib, and Repotrectinib have shown efficacy in specific genetic subtypes of NSCLC, such as ALK and ROS1 rearrangements. These alternatives offer various options depending on the specific genetic alterations present in the cancer.

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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.

Must not have

Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.

Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal Trial

Summary

This trial is testing if the drug selpercatinib can safely and effectively prevent lung cancer from returning in patients who have had treatment. It focuses on people with early-stage lung cancer. The drug works by blocking proteins that help cancer cells grow.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has come back or gotten worse after treatment.

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I have or had lung scarring or inflammation that needed steroids.

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I have been treated with a specific medication for cancer before.

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I have not had major surgery in the last 4 weeks.

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I have been diagnosed with small cell lung cancer.

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I have an active hepatitis B or C infection.

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I do not have uncontrolled HIV.

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I haven't had a heart attack in the last 6 months and my heart's electrical activity is normal.

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I do not have any uncontrolled infections or serious illnesses like high blood pressure or diabetes.

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I do not have a condition that affects how my body absorbs medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-Free Survival (EFS)

Secondary study objectives

EFS

Mean Change from Baseline over Time in NSCLC Symptoms

Mean Change from Baseline over Time in Physical Function

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies that focus on specific genetic mutations within cancer cells. Selpercatinib, a RET kinase inhibitor, works by selectively targeting and inhibiting the RET protein, which is involved in cell growth and division. This inhibition can prevent the proliferation of cancer cells with RET fusions, leading to tumor shrinkage and delayed progression. Other targeted therapies include inhibitors for EGFR, ALK, and ROS1 mutations, which similarly block the activity of proteins that drive cancer growth. These treatments are crucial for NSCLC patients as they offer more personalized and effective options compared to traditional chemotherapy, often resulting in better outcomes and fewer side effects.

External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer.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.Selpercatinib in RET-fusion positive metastatic non-small cell lung cancer: achievements and gray areas.