A PHASE II STUDY OF TALAZOPARIB FOR PREVIOUSLY TREATED HOMOLOGOUS RECOMBINATION REPAIR DEFICIENCY POSITIVE PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER (LUNG-MAP SUB-STUDY)

(In addition to S1400 Lung-MAP common criteria)

Sub-Study Specific Disease Related Criteria

a. Patients must be assigned to S1400G. S1400G biomarker eligibility defined as Homologous Recombination Repair Deficiency (HRRD) Positive.


b. 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. For information and a list of PARP inhibitors, please consult the S1400G � Poly Polymerase Inhibitors, Scott et al., 2015 JCO ref from the link on the S1400G protocol abstract page of the SWOG (http://swog.org) or CTSU (https://www.ctsu.org) websites.

c. 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.

Sub-Study Specific Clinical/Laboratory Criteria

a. 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).

b. Patients must be able to take oral medications. Patients must be able to swallow capsules whole without crushing or altering them in any way.

c. Patients must not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors (see Section 3.1.c.3 for list of medications).�

d. Patients must agree to have blood specimens submitted for pharmacokinetic analysis as outlined in Section 15.3.