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A Phase II Study of Talazoparib Plus Avelumab in Patients With Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

Primary Objectives To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with Stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. To evaluate disease control rate at 12 weeks (DCR12) after registration. Secondary Objectives To evaluate investigator assessed progression-free survival (IA-PFS). To evaluate overall survival (OS). To evaluate duration of response (DOR) among responders. To evaluate the frequency and severity of toxicities. Translational Medicine Objectives To collect, process, and bank cell-free DNA (cfDNA) at baseline, Cycle 3 Day 1, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and examine molecular mechanisms of resistance to talazoparib and avelumab. Note: The translational medicine proposal to use these specimens will be submitted as a revision to CTEP for approval, prior to commencing next-generation sequencing (NGS) assays. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC). To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc. (FMI) panel from the LUNGMAP screening protocol. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol. To evaluate the association between tumor mutational burden (TMB) measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes (ORR, IA-PFS, OS).

Primary Objectives To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with Stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. To evaluate disease control rate at 12 weeks (DCR12) after registration. Secondary Objectives To evaluate investigator assessed progression-free survival (IA-PFS). To evaluate overall survival (OS). To evaluate duration of response (DOR) among responders. To evaluate the frequency and severity of toxicities. Translational Medicine Objectives To collect, process, and bank cell-free DNA (cfDNA) at baseline, Cycle 3 Day 1, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and examine molecular mechanisms of resistance to talazoparib and avelumab. Note: The translational medicine proposal to use these specimens will be submitted as a revision to CTEP for approval, prior to commencing next-generation sequencing (NGS) assays. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC). To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc. (FMI) panel from the LUNGMAP screening protocol. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol. To evaluate the association between tumor mutational burden (TMB) measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes (ORR, IA-PFS, OS).