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Protocol No. S1900C

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations

Objective The purpose of this study is to test the good and bad effects of the combination of drugs called talazoparib and avelumab. Talazoparib and avelumab could shrink your cancer, but it could also cause side effects, which are described in the risks section

Treatment
  • Talazoparib: You will take talazoparib by mouth once a day, at around the same time each day (preferably in the morning). It is important to swallow whole and not to chew the capsules. Talazoparib can be taken with or without food. Always use gloves when handling talazoparib capsules
  • Avelumab: You will be given avelumab through your vein over 60 minutes, followed by a 30-minute observation time, once every two weeks, in a clinical setting. You will also receive an antihistamine and acetaminophen 30-60 minutes before you start the first four cycles of avelumab to help prevent allergic reactions. You may continue to receive an antihistamine and acetaminophen after four cycles

  • Description Phase II Study of Talazoparib plus Avelumab in Recurrent Non-Squamous NSCLC bearing STK11 alterations

    Key Eligibility
  • 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
  • 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
  • Evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to sub-study registration
  • Known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to sub-study registration
  • 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
  • Must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for Stage III, IV or recurrent disease as defined by the protocol
  • Any number of additional, non-platinum-based chemotherapy or targeted therapy regimens for recurrent or metastatic disease are allowed
  • Must be able to swallow capsules whole
  • Must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib) as its primary pharmacology
  • Must have progressed (in the opinion of the treating physician) following their most recent line of therapy
  • Must have measurable disease as defined by the protocol
  • 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 metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
  • Must have adequate hepatic, hematologic and renal function as defined by the protocol
  • Zubrod performance status 0-1
  • Must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria as defined by the protocol
  • Can not be pregnant or breast feeding
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Must not have a history of prior organ transplantation, including allogeneic stem-cell transplantation
  • Must not have any history of anaphylaxis or uncontrolled asthma as defined by the protocol
  • Must not have evidence of active infection requiring systemic therapy
  • 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
  • Must not have impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib as defined by the protocol. Patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis within 12 months prior to sub-study registration

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park