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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)

Primary Objective a. 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: i. Cohort 1: Patients with squamous cell histology or mixed histology with a squamous component ii. Cohort 2: Patients with non-squamous histology (adenocarcinoma, large cell, or NSCLC NOS) Secondary Objectives a. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with rucaparib within each cohort. b. To evaluate duration of response among responders within each cohort. c. To evaluate the frequency and severity of toxicities associated with rucaparib among all patients enrolled on the study (combining cohorts). Translational Medicine Objectives a. To evaluate the association between alterations in DNA repair genes and response by RECIST 1.1. b. 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. c. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

Primary Objective a. 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: i. Cohort 1: Patients with squamous cell histology or mixed histology with a squamous component ii. Cohort 2: Patients with non-squamous histology (adenocarcinoma, large cell, or NSCLC NOS) Secondary Objectives a. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with rucaparib within each cohort. b. To evaluate duration of response among responders within each cohort. c. To evaluate the frequency and severity of toxicities associated with rucaparib among all patients enrolled on the study (combining cohorts). Translational Medicine Objectives a. To evaluate the association between alterations in DNA repair genes and response by RECIST 1.1. b. 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. c. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).