Talazoparib and Thoracic RT for ES-SCLC

Official Title

A Phase I Study of Talazoparib and Consolidative Thoracic Radiation Therapy for Extensive Stage Small Cell Lung Cancer

Summary:

This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiation therapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiation therapy. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.

Trial Description

Primary Outcome:

• Safety of Talazoparib in Combination with Low Dose Thoracic Radiation Therapy
• Maximum Tolerated Dose (MTD) of Talazoparib in Combination with Low Dose Thoracic Radiation Therapy

Secondary Outcome:

• Loco-regional Recurrence
• Progression-Free Survival (PFS)
• Overall Survival (OS)
• Acute Toxicities
• Chronic Toxicities

This is a phase I, dose escalating study evaluating the safety of combination talazoparib and low dose consolidative thoracic radiation therapy for extensive-stage small cell lung cancer patients with at least stable disease after standard of care 4 - 6 cycles of chemotherapy (a platinum agent and etoposide). This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiation therapy. Secondary objectives will be to examine clinical outcomes, including locoregional recurrence within the radiation field, progression-free survival, overall survival and acute/chronic toxicities up to 1 year. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of RT. Patient will start low dose RT on day 6-9, and will continue for 10 fractions throughout 2 weeks. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort. Patients will be monitored weekly during study treatment, and followed up at 3 weeks, and every 3 months after for 1 year.

View this trial on ClinicalTrials.gov