This study wants to find out how well talazoparib (Talzenna) and temozolomide (Temodal) work for treating patients with small cell lung cancer that has come back after or was unresponsive to initial chemotherapy. The main outcome that will be measured is how long the patients go before the cancer grows. The study is being conducted in California, the United States.
The details
Talazoparib and temozolomide are anti-cancer medications. They are not usually used to treat small cell lung cancer. It is not known if using these medications as a second line therapy after initial chemotherapy has failed, will work.
This study wants to find out how well talazoparib and temozolomide work for treating patients with unresponsive or relapsed small cell lung cancer. The main outcome that will be measured is how long the patients go before the cancer grows.
Who are they looking for?
28 patients with extensive stage small cell lung cancer are being recruited. Female participants cannot be pregnant, planning to get pregnant or be breastfeeding. Male participants must use condoms during the trial. Patients must have a tumor sample for tests and must have adequate bone marrow, liver and kidney function.
Patients cannot have received more than one prior type of treatment. Patients cannot have been treated with similar drugs to the study drugs. Patients cannot have any other serious medical issues such as heart issues, another cancer or gastrointestinal issues.
How will it work
All of the patients will receive the same treatment. Patients will receive treatment with temozolomide on days 1-5 and talazoparib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Response rate and survival without cancer growing will be evaluated up to 1 year.
