← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My lung cancer is RET fusion-positive.

Select...

I can swallow pills.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I can carry out all my usual activities without help.

Select...

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

Select...

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

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

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

Primary outcome measures

Response rate by blinded independent centralized review (BICR)

Secondary outcome measures

BICR-duration of response (DOR)

BICR-progression-free survival (PFS)

Central nervous system (CNS) response rate

+4 more

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 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,687 Total Patients Enrolled

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

265,046 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,029 Total Patients Enrolled

Media Library

Selpercatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04268550 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Treatment (selpercatinib)

Non-Small Cell Lung Cancer Clinical Trial 2023: Selpercatinib Highlights & Side Effects. Trial Name: NCT04268550 — Phase 2

Selpercatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268550 — Phase 2

Frequently Asked Questions

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

Are there any analogous studies to this one?

"At the moment, there are 11 active Selpercatinib studies in 584 cities and 34 nations. This drug's testing began back in 2017, when Eli Lilly & Co ran a Phase 1 & 2 clinical trial of 875 patients as part of their attempt to gain approval. Since then, 14 more trials have been completed successfully."

Answered by AI

What is the current count of healthcare facilities engaged in this research?

"Patients can apply to be part of this trial at multiple sites, such as Genesis Healthcare System Cancer Care Center in Zanesville, Ohio; University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma; and Randolph Hospital in Asheboro, North carolina. A full list of 100 locations is available online."

Answered by AI

Can you elucidate the risks posed by Selpercatinib for individuals?

"Our analysts at Power have allocated a score of 2 to Selpercatinib's safety, as this is still in its Phase 2 trials and lacks evidence backing up efficacy."

Answered by AI

Is this scientific research currently seeking participants?

"Clinicaltrials.gov documents this trial, which was first published on February 10th 2020 and most recently updated in September 7th 2022, is not accepting new patients at the moment; however there are 1,916 other trials actively recruiting participants currently."

Answered by AI

For what medical conditions is Selpercatinib commonly prescribed?

"The usual treatment for medullary carcinoma of the thyroid is Selpercatinib. This medication also has properties to address radioiodine-refractory cases, as well as instances necessitating systemic therapy."

Answered by AI

How many individuals are being observed as part of this research experiment?

"This clinical trial is no longer recruiting participants. The posting was initially published on February 10th 2020 and the latest update occurred September 7th 2022. For those seeking other studies, there are currently 1905 investigations searching for patients with stage IVA lung cancer AJCC V8 and 11 tests actively enrolling volunteers to take Selpercatinib."

Answered by AI

Are there any prior investigations that have focused on Selpercatinib?

"Selpercatinib was first tested in 2017 at Severance Hospital. Over the last few years, there have been 14 completed studies on the drug and 11 ongoing investigations primarily based in Zanesville, Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

2020. "Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04268550.

All > Alaska