Arm A (carboplatin, pemetrexed, selpercatinib) for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moffitt Cancer Center, Tampa, FL
Non-Small Cell Lung Carcinoma (NSCLC)+7 More
Carboplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II Lung-MAP treatment trial tests whether carboplatin and pemetrexed with or without selpercatinib works to shrink tumors in patients with RET fusion-positive non-small cell lung cancer that is stage IV or has not responded to previous RET directed therapy. Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib in combination with carboplatin and pemetrexed may help lower the chance of the cancer growing and spreading.

Eligible Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Stage IVB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IVA Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Day 21
Incidence of grade 3 or higher non hematologic toxicity and grade 4 or higher hematologic toxicity
Year 3
Duration of investigator-assessed response
Year 3
Overall survival
Year 3
Investigator-assessed progression-free survival (PFS)
Up to 3 years
Frequency and severity of adverse events
Investigator-assessed objective response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Trial Design

2 Treatment Groups

Arm B (carboplatin, pemetrexed)
1 of 2
Arm A (carboplatin, pemetrexed, selpercatinib)
1 of 2
Active Control
Experimental Treatment

74 Total Participants · 2 Treatment Groups

Primary Treatment: Arm A (carboplatin, pemetrexed, selpercatinib) · No Placebo Group · Phase 2

Arm A (carboplatin, pemetrexed, selpercatinib)Experimental Group · 3 Interventions: Carboplatin, Selpercatinib, Pemetrexed · Intervention Types: Drug, Drug, Drug
Arm B (carboplatin, pemetrexed)ActiveComparator Group · 2 Interventions: Carboplatin, Pemetrexed · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6570
Selpercatinib
2021
Completed Phase 2
~520
Pemetrexed
2014
Completed Phase 3
~5260

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Moffitt Cancer Center · Tampa, FL
Photo of moffitt cancer center  1Photo of moffitt cancer center  2Photo of moffitt cancer center  3
2009First Recorded Clinical Trial
19 TrialsResearching Non-Small Cell Lung Carcinoma (NSCLC)
221 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization.
Participants must have received and developed disease progression during or after an anti-RET inhibitor treatment
Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
For participants with stage IV or recurrent disease, the participant must not have received a platinum-based chemotherapy regimen

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.