Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA 1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung Map Sub-Study)

April 21, 2020

Clinical Trial Information

SCHEMA

PROTOCOL: SWOG-S1900A (Lung Map Sub-Study)

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Patients must be assigned to S1900A. S1900A biomarker eligibility defined as LOH high and/or deleterious BRCA1/2 mutation.
  2. Patients must not have had prior treatment with any PARP inhibitor, including rucaparib, talazoparib, veliparib, olaparib, or niraparib.
  3. Patients must be able to take oral medications.
  4. Patients must not be planning to receive any concurrent chemotherapy or small molecular or hormonal therapy within 21 days and biologics (e.g. bevacizumab, necitumumab or ramucirumab) or immunotherapy within 28 days prior to sub-study registration and while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  5. Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy.
  6. Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
  7. Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (≤ Grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration.
  8. Patients must have measurable disease.
  9. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration.
  10. Patient must not have had a major surgery within 14 days prior to substudy registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator.
  11. Patients must have Zubrod performance status 0-1.
  12. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.

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