Study on Rucaparib and Pembrolizumab for Ongoing Treatment in Stage IV Non-Squamous Non-Small Cell Lung Cancer

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03559049

Provider View

This clinical trial is testing a combination of two drugs, rucaparib and pembrolizumab, to see if they are safe and effective as ongoing treatment for patients with stage IV non-squamous non-small cell lung cancer (NSCLC) who have not shown disease progression after initial therapy.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of using rucaparib, taken orally, together with pembrolizumab, given through an IV, as maintenance treatment for patients with stage IV non-squamous non-small cell lung cancer (NSCLC). This trial is for patients whose cancer has not worsened after receiving initial treatment with a combination of carboplatin, pemetrexed, and pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Be willing and able to provide written consent to participate in the trial.
  • Be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Have stage IV non-squamous NSCLC without specific genetic mutations (EGFR, BRAF, ALK, or ROS-1) and at least one measurable tumor.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function as determined by medical tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 180 days after the last dose.
  • Men must agree to use effective birth control during the study and for 180 days after the last dose.
  • Provide a previous tumor sample if available, but a new biopsy is not required.

Exclusion Criteria

  • Have received previous treatment for stage IV NSCLC.
  • Have had radiation to the lungs over a certain dose within 6 months before joining the study.
  • Have had recent palliative radiation within 7 days before joining the study.
  • Have had prior treatment with certain immune therapies or PARP inhibitors.
  • Have a history of another cancer unless treated successfully with no return for 5 years.
  • Have active cancer spread to the brain or spinal cord.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Need daily corticosteroids over a certain dose.
  • Have lung disease or a history of lung inflammation needing treatment.
  • Have an active infection needing treatment.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 180 days after.
  • Have an immune deficiency or are on immunosuppressive therapy recently.
  • Have a history of active tuberculosis.
  • Have active hepatitis B or C.
  • Have received a live vaccine within 30 days before joining the study.
  • Have a medical condition needing daily systemic corticosteroids over a certain dose.

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