Study on Talazoparib and Low-Dose Temozolomide for Treating Relapsed or Hard-to-Treat Extensive-Stage Small Cell Lung Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03672773

Provider View

This clinical trial is exploring the effectiveness of combining two drugs, talazoparib and temozolomide, to treat extensive-stage small cell lung cancer that has returned or is not responding to initial chemotherapy. The study aims to see if this combination works better than using either drug alone.

Patient Parameters

Program Overview

This phase II study is testing how well the combination of talazoparib and temozolomide works for patients with extensive-stage small cell lung cancer that has come back or is not responding to initial treatment. Talazoparib is a PARP inhibitor that may stop tumor cells from growing by preventing them from repairing their DNA. Temozolomide is a chemotherapy drug that can kill tumor cells or stop them from spreading. The study hopes to find out if using both drugs together is more effective than using them separately.

Description

The main goal of this study is to see how effective the combination of talazoparib and temozolomide is in treating extensive-stage small cell lung cancer by measuring the response rate of the tumors.

Secondary goals include:

  • Evaluating how long patients live without the cancer getting worse (progression-free survival) and overall survival.
  • Assessing how long the response to treatment lasts and how quickly it starts.
  • Checking the safety and tolerability of the drug combination.
  • Studying how the body processes talazoparib when taken with temozolomide.
  • Gathering patient feedback on side effects using a specific questionnaire.

Exploratory goals include:

  • Identifying any biological markers that might predict how well patients respond to the treatment.

Participants will take temozolomide by mouth on days 1-5 and talazoparib daily on days 1-28. This cycle repeats every 28 days as long as the cancer does not progress and side effects are manageable. After finishing the treatment, participants will have follow-up visits at 30 days and then up to one year.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide informed consent.
  • Have a confirmed diagnosis of extensive-stage small cell lung cancer.
  • Cancer must have returned within 6 months or not responded to initial platinum-based chemotherapy.
  • Have measurable disease according to specific medical criteria.
  • Must provide a tissue sample for further analysis.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must be able to swallow the study drugs and have no known allergies to them.
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Male participants must use a condom during and after the study and consider birth control for female partners.
  • Must agree not to donate sperm or eggs during and after the study.
  • Female participants must not be breastfeeding during and after the study.
  • Must meet specific blood count and organ function criteria.

Exclusion Criteria

  • Have not fully recovered from side effects of previous treatments, except for hair loss or certain lab abnormalities.
  • Cancer did not respond to first-line platinum chemotherapy.
  • Have received more than one line of chemotherapy.
  • Have previously been treated with a PARP inhibitor or temozolomide.
  • Have used cancer treatments or investigational drugs within 14 days before starting the study.
  • Have had major surgery within 14 days before starting the study.
  • Have a diagnosis of myelodysplastic syndrome.
  • Have a gastrointestinal disorder affecting drug absorption.
  • Are using certain medications that interfere with the study drugs.
  • Have had another cancer within the last two years, except for certain early-stage cancers.
  • Have any condition that interferes with study participation or poses a risk, as determined by the investigator.

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