Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extens… (NCT03672773) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer
United States35 participantsStarted 2018-10-31
Plain-language summary
This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to provide informed consent.
* Cytologically or histologically confirmed small cell lung cancer (SCLC) with extensive-stage disease.
* Relapsed (progressed within 6 months) or refractory (progressed during or within 4 weeks of completing 1st line platinum based regimen).
* Measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Archival or fresh tissue biopsy available for exploratory analyses.
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1.
* Able to swallow the study drugs, has no known intolerance to study drugs or excipients, and able to comply with study requirements.
* Female participants of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method (defined in protocol) from the time of the first study drug treatment through 45 days after the last study drug treatment.
* Male participants must use a condom when having sex from the time of the first study drug treatment through 105 days after the last study drug treatment. Contraception should be considered for a non-pregnant female partner of childbearing potential.
* Male and female participants must agree not to donate sperm or eggs, respectively, from the first study drug treatment through 105 days and 45 days after the last study drug treatment, respectively.
* Female participants may not be breastfeeding at baseline through 45 days after the last study drug…
What they're measuring
1
Objective response rate defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIS)T 1.1