Talazoparib + Radiotherapy for Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs like strong P-gp inhibitors or other P-gp and BCRP inhibitors while participating. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Talazoparib in combination with radiotherapy for treating small cell lung cancer?
What makes the drug Talazoparib unique for treating small cell lung cancer?
Talazoparib is unique because it is a PARP inhibitor that enhances the effectiveness of radiotherapy by increasing DNA damage in cancer cells, making them more sensitive to radiation. This combination approach is novel for small cell lung cancer, which is an aggressive type of cancer with limited treatment options.12678
Research Team
Benjamin Lok, MD
Principal Investigator
Princess Margaret Cancer Center
Eligibility Criteria
This trial is for adults with extensive-stage small cell lung cancer who finished 4-6 cycles of specific chemotherapy without disease progression. They must be able to swallow pills, have good organ function, and not be pregnant or breastfeeding. Excluded are those with untreated brain metastases, prior PARP inhibitor treatment, recent other cancer treatments, serious medical conditions or infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talazoparib starting on day 1 and low dose thoracic radiotherapy starting on day 6-9 for 10 fractions over 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Low Dose Radiotherapy (RT)
- Talazoparib
Talazoparib is already approved in United States, European Union for the following indications:
- Deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer
- Monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University