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

Active:	No
Cancer Type:	Lung Cancer	NCT ID:	NCT04268550
Trial Phases:	Phase II	Protocol IDs:	S1900B (primary) S1900B NCI-2019-08097
Eligibility:	0 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	SWOG
NCI Full Details:	http://clinicaltrials.gov/show/NCT04268550

Summary

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the objective response rate (ORR) (confirmed complete or partial response) associated with selpercatinib (LY3527723) in patients with previously-treated stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:
I. To evaluate the duration of response among responders.
II. To evaluate the frequency and severity of toxicities.
III. To evaluate investigator-assessed progression-free survival (IA-PFS).
IV. To evaluate overall survival (OS).
V. Among patients with brain metastases at baseline:
Va. To evaluate the central nervous system (CNS) response rate (confirmed complete response [CR]);
Vb. To evaluate the duration of intracranial response among patients with a CNS response.

TRANSLATIONAL MEDICINE OBJECTIVES:
I. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA).
II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

OUTLINE:
Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of 3 years from date of sub-study registration.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.