NCT03845296

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Phase II Study of Rucaparib in Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) associated with rucaparib in patients with genomic LOH high and/or deleterious BRCA1/2 mutations within: Cohort 1: Patients with squamous cell histology or mixed histology with a squamous component; Cohort 2: Patients with non-squamous histology (adenocarcinoma, large cell, or non-small cell lung cancer \[NSCLC\] not otherwise specified \[NOS\]). SECONDARY OBJECTIVES: I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with rucaparib within each cohort. II. To evaluate duration of response among responders within each cohort. III. To evaluate the frequency and severity of toxicities associated with rucaparib among all patients enrolled on the study (combining cohorts). TRANSLATIOAL MEDICINE OBJECTIVES: I. To evaluate the association between alterations in deoxyribonucleic acid (DNA) repair genes and response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To perform comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) at baseline in all patients to assess its clinical utility in comparison to tumor tissue biomarker profiles. III. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients receive rucaparib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for up to 3 years.

Conditions

• Deleterious BRCA1 Gene Mutation
• Deleterious BRCA2 Gene Mutation
• Loss of Heterozygosity
• Lung Non-Small Cell Squamous Carcinoma
• Recurrent Large Cell Lung Carcinoma
• Recurrent Lung Adenocarcinoma
• Recurrent Lung Non-Small Cell Carcinoma
• Recurrent Non-Squamous Non-Small Cell Lung Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Rucaparib	Given PO

Timeline

• Start date: 2019-04-16
• Primary completion: 2022-01-01
• Completion: 2024-09-21
• First posted: 2019-02-19
• Last updated: 2025-05-21
• Results posted: 2022-10-19

Locations

950 sites across 1 country: United States

Regulatory

• FDA-regulated drug study