Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squmaous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (Lung Map Sub-Study)

April 23, 2020

Clinical Trial Information

SCHEMA

PROTOCOL: SWOG-S1900C

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 S1900C. Assignment to S1900C is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900C is based on the identification of a pathogenic somatic mutation in STK11 or STK11 bi-allelic loss on tumor.
  2. Patients must have histologically or cytologically confirmed Stage IV or recurrent non-squamous, mixed squamous/non-squamous (e.g., adeno-squamous carcinoma), or non-small cell lung cancer not otherwise specified (NSCLC NOS). Patients with pure squamous cell carcinoma are not eligible.
  3. Patients must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for Stage III, IV or recurrent disease.
  4. Any number of additional, non-platinum-based chemotherapy or targeted therapy regimens for recurrent or metastatic disease are allowed.
  5. Patients may not have received more than one line of anti-PD-1 or antiPD-L1 therapy in the Stage IV or recurrent setting. Anti-PD-1 or anti-PDL1 therapy may have been given alone or in combination with platinumbased chemotherapy, an anti-CTLA4 therapy, or other immunemodulatory therapy. Patients must have experienced disease progression>42 days following initiation (Cycle 1 Day 1) of the anti-PD-1 or anti-PD-L1 containing regimen.
  6. Patients who did not receive anti-PD-1 or anti-PD-L1 therapy in combination with platinum-based chemotherapy, must have also received prior platinum-based chemotherapy and experienced disease progression >42 days following initiation (Cycle 1 Day 1) of platinum based chemotherapy.
  7. Patients who received anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of antiPD-1 or anti-PD-L1 therapy, are eligible if they experienced disease progression less than (<) 365 days from the date of initiation of anti-PD-1 or anti-PD-L1 therapy.
  8. Patients who received prior adjuvant platinum-based therapy post-surgical resection for Stage I-III disease (i.e. the patient has not received platinum-based chemotherapy for Stage IV or recurrent disease) must have had disease progression during or after platinum-based chemotherapy that occurred less than (<) 365 days from the last date that the patient received that therapy.
  9. Patients must be able to swallow capsules whole.
  10. Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib) as its primary pharmacology.
  11. Patients must not be taking, nor plan to take while on protocol treatment strong Pgp inhibitors (e.g. droneradone, quinidine, ranolazine, itraconazole, ketononazole), P-gp inducers (rifampin, ritonavir, tipranavir), or strong breast cancer resistance
    protein (BCRP) inhibitors (e.g. elacridar).
  12. Patients must have progressed following their most recent line of therapy.
  13.   Patients must not have received prior systemic immunotherapy within 28 days prior to sub-study registration and must not have received any prior systemic therapy (including systemic chemotherapy 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. (See 5.2c.2 for criteria regarding therapy for CNS metastases).
  14. Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment 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.
  15. Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator.
  16. Patients must have Zubrod performance status 0-1.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

Newsletter

Ⓒ 2020 Genesys Hurley Cancer Institute | All Rights Reserved.