Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer
Condition: ATM Gene Mutation; ATR Gene Mutation; BARD1 Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; BRIP1 Gene Mutation; CHEK1 Gene Mutation; CHEK2 Gene Mutation; FANCA Gene Mutation; FANCC Gene Mutation; FANCD2 Gene Mutation; FANCF Gene Mutation; FANCM Gene Mutation; NBN Gene Mutation; PALB2 Gene Mutation; RAD51 Gene Mutation; RAD51B Gene Mutation; RAD54L Gene Mutation; Recurrent Squamous Cell Lung Carcinoma; RPA1 Gene Mutation; Stage IV Squamous Cell Lung Carcinoma AJCC v7
MeSH terms: Carcinoma; Lung Neoplasms
Intervention: Laboratory Biomarker Analysis; Pharmacological Study; Talazoparib
Intervention description: Correlative studies; Correlative studies; Given PO
Intervention MeSH terms: Talazoparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies how well talazoparib works in treating patients with homologous
      recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has
      come back after previous treatment. Talazoparib may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON
             ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master
             Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

          -  Patients must be assigned to S1400G; S1400G biomarker eligibility defined as
             homologous recombination repair deficiency (HRRD) positive is as follows

               -  Biomarker-positive group

                    -  HRRD by FMI

                         -  Homologous recombination repair deficiency by Foundation Medicine Inc.,
                            criteria

               -  Alteration type

                    -  Truncating mutation, frameshift deletions, indels missense and nonsense
                       mutations predicted to have functional consequence in any of the specified
                       genes

               -  Eligible alteration

                    -  Mutation in any one of the following critical HRR pathway genes: ATM, ATR,
                       BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF,
                       FANCM, NBN (NBS1), PALB2, RAD51, RAD51B (RAD51L1), RAD54L, RPA1

          -  Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g.,
             veliparib, olaparib, rucaparib, niraparib, talazoparib [BMN 673]) as its primary
             pharmacology

          -  Patients must have achieved stable disease, a partial response, or a complete response
             at their first disease assessment after initiating first-line platinum-based
             chemotherapy; patients determined to have progressed (in the opinion of the treating
             physician) at their first disease assessment are not eligible

          -  Patients may not have any impairment of gastrointestinal function or gastrointestinal
             disease that may significantly alter the absorption of talazoparib (BMN 673) (e.g.,
             ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome,
             small bowel resection, or active peptic ulcer disease); patients must not have active
             small or large intestine inflammation such as Crohn's disease or ulcerative colitis
             (within 12 months of sub-study registration)

          -  Patients must be able to take oral medications; patients must be able to swallow
             capsules whole without crushing or altering them in any way

          -  Patients must not be taking, nor plan to take while on protocol treatment strong
             P-glycoprotein (P-gp) inhibitors, P-gp inducers, or breast cancer resistance protein
             (BCRP) inhibitors; the language ?P-gp or BCRP inhibitors or inducers? is reworded to
             ?strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors? for consistency with the
             investigator brochure

          -  Patients must agree to have blood specimens submitted for pharmacokinetic analysis