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Anti-tumor antibiotic

Targeted Therapy with Selpercatinib for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Led By Yasir Y Elamin
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have stage IV or recurrent disease
Participants must have an electrocardiogram (ECG) performed within 28 days prior to sub-study randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial tests whether combining different drugs may be more effective than existing treatments for patients with a specific type of lung cancer.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that's RET fusion-positive and either stage IV or resistant to previous RET therapy. They must be able to swallow pills, have no major surgeries within the last 14 days, not be pregnant/nursing, and agree to use contraception. Excluded are those with certain heart diseases, untreated brain metastases, or other cancers that could affect the trial's safety or results.Check my eligibility
What is being tested?
The study tests if adding Selpercatinib (a targeted drug blocking enzymes for cell growth) to chemotherapy drugs Carboplatin and Pemetrexed can shrink tumors better in patients with specific genetic changes in their lung cancer cells. It's a phase II trial where some participants will receive this combination treatment while others won't.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue from chemotherapy drugs; Selpercatinib may cause high blood pressure, liver enzyme increase, dry mouth or diarrhea. Side effects vary by individual and should be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at stage IV or has come back.
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I had an ECG test within the last 28 days.
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I can safely join the study despite my decision-making challenges.
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My condition worsened after treatment with anti-RET inhibitors.
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I have had a brain scan within the last 42 days.
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I can swallow pills.
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My cancer is at stage IV or has come back.
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I have recovered from side effects of my previous treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had a physical exam within the last 28 days.
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My NSCLC is RET fusion-positive based on biomarker tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Investigator-assessed progression-free survival (PFS)
Secondary outcome measures
Duration of investigator-assessed response
Frequency and severity of adverse events
Incidence of grade 3 or higher non hematologic toxicity and grade 4 or higher hematologic toxicity
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (carboplatin, pemetrexed, selpercatinib)Experimental Treatment3 Interventions
Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also selpercatinib PO BID in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (carboplatin, pemetrexed)Active Control2 Interventions
Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Selpercatinib
2021
Completed Phase 1
~600

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,536 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,581 Previous Clinical Trials
41,224,912 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,177 Total Patients Enrolled

Media Library

Carboplatin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05364645 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A (carboplatin, pemetrexed, selpercatinib), Arm B (carboplatin, pemetrexed)
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05364645 — Phase 2
Carboplatin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364645 — Phase 2

Frequently Asked Questions

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

Are we still looking for participants in this research?

"The most recent information on clinicaltrials.gov suggests that this clinical trial is still recruiting patients. Thetrial was originally posted on 7/25/2022 and has since been updated on 8/16/2022."

Answered by AI

Are there any known serious side effects of Selpercatinib?

"Selpercatinib's safety is unknown because there is no efficacy data, but it received a score of 2 due to the available safety data."

Answered by AI

How many people are being signed up to participate in this test?

"That is correct, the information available on clinicaltrials.gov shows that this study is looking for 74 patients at 1 location. The posting went up on 7/25/2022 and was last updated 8/16/2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Pacific Medical Center-Pacific Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~49 spots leftby May 2028