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Tyrosine Kinase Inhibitor

Selpercatinib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Yasir Y Elamin

Research Sponsored by Southwest Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must have RET fusion-positive NSCLC as determined by specific assays such as FMI tissue-assay, NGS, PCR, FISH, or cfDNA blood assay

Patients must be able to swallow capsules

Must not have

Patients must not have uncontrolled diabetes, uncontrolled blood pressure and hypertension, or impairment of gastrointestinal function

Patients must not have had a major surgery within 14 days prior to sub-study registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from date of sub-study registration

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer. Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that tests positive for RET fusion. Participants must have tried platinum-based chemotherapy, be able to swallow capsules, and not have other major health issues or recent surgeries. They can't join if they've used anti-RET drugs before or are pregnant/nursing.

What is being tested?

The study is testing Selpercatinib's effectiveness on stage IV or recurrent non-small cell lung cancer with RET fusion. It aims to see if the drug can halt tumor growth by inhibiting specific enzymes needed by cancer cells.

What are the potential side effects?

Selpercatinib may cause side effects such as high blood pressure, liver enzyme changes, dry mouth, diarrhea, constipation, fatigue, swelling in hands/feet, rash and possibly affect heart rhythm (QTc prolongation).

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is RET fusion-positive.

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I can swallow pills.

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I've had platinum-based chemotherapy for advanced or recurrent cancer.

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My NSCLC is RET fusion-positive based on biomarker tests.

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I have chronic hepatitis B but it's under control with medication.

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My cancer does not have mutations that would resist LOXO-292 treatment.

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I can carry out all my usual activities without help.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

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I have HIV, am on treatment, and my viral load is undetectable.

Exclusion Criteria

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

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I do not have uncontrolled diabetes, high blood pressure, or issues with my digestive system.

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I have not had any major surgery in the last 14 days.

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I am not planning to take strong CYP3A4 drugs or proton pump inhibitors.

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I am not planning to receive any other cancer treatments like chemotherapy or immunotherapy.

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I do not have cancer spread to the brain, spinal cord, or its coverings.

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I have never been treated with drugs specifically targeting the RET gene.

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I do not have severe heart disease, recent heart attacks, or uncontrolled heart rhythm problems.

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I haven't had any cancer treatment in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from date of sub-study registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from date of sub-study registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from date of sub-study registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response rate by blinded independent centralized review (BICR)

Secondary study objectives

BICR-duration of response (DOR)

BICR-progression-free survival (PFS)

Central nervous system (CNS) response rate

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (selpercatinib)Experimental Treatment1 Intervention

Patients receive selpercatinib orally PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selpercatinib

2021

Completed Phase 1

~600

0 / 17Eligibility criteria met