Study ID: S1400-G
A phase 2 study of talazsoparib in patients with homologous recombination repair deficiency positive stage 4 squamous cell lung cancer
This treatment trial is for patients who have been diagnosed with stage 4 squamous cell lung cancer and whose tumors have tested positive for homologous recombination repair deficiency.
Participants receive the oral anti-cancer drug talazoparib daily for 21 days. Courses then repeat every 21 days as long as the disease does not progress and no toxicity occurs.
- Must be assigned to S1400G biomarker eligibility defined as Homologous Recombination Repair Deficiency (HRRD) positive, as per protocol.
- 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.
- 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.
- Must not have any impairment of GI function or GI 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).
- 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 swallow capsules whole without crushing or altering them.
- Must not be taking, nor plan to take while on protocol treatment, strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors (see protocol for list of medications).
- Must agree to have blood specimens submitted for pharmacokinetic analysis as outlined in protocol.
Treatment: talazoparib 1000 mcg PO daily continuous
- Must have been diagnosed with squamous cell lung cancer
- Must not have a compromised gastrointestinal function or GI disease
- Must be able to swallow capsules whole without crushing or altering them