Your session is about to expire
← Back to Search
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 Zubrod performance status 0-1 documented within 28 days prior to sub-study randomization
Participants must have received and developed disease progression during or after an anti-RET inhibitors treatment
Must not have
Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My condition worsened after treatment with anti-RET inhibitors.
Select...
I can swallow pills.
Select...
My cancer is at stage IV or has come back.
Select...
My NSCLC is RET fusion-positive based on biomarker tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not planning to receive any other cancer treatments while on this study.
Select...
I do not have severe heart disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreTrial 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
395 Previous Clinical Trials
265,074 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,327 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.My condition worsened after treatment with anti-RET inhibitors.I have had a physical exam within the last 28 days.I have recovered from side effects of my previous treatment.I have had a brain scan within the last 42 days.I can swallow pills.I had an ECG test within the last 28 days.I do not have another cancer that could affect this treatment's safety or results.I have not had any major surgery in the last 14 days.My cancer is at stage IV or has come back.I don't have cancer spread to the brain or spinal cord, or if I do, it's been treated and stable for 14 days without symptoms.I haven't had any cancer treatment in the last 14 days.I am not planning to receive any other cancer treatments while on this study.You need to have a clear sign of the disease shown in CT or MRI scans.I do not have severe heart disease.I can safely join the study despite my decision-making challenges.My NSCLC is RET fusion-positive based on biomarker tests.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (carboplatin, pemetrexed, selpercatinib)
- Group 2: Arm B (carboplatin, pemetrexed)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger