CompletedPhase 2NCT03377556

Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous Cell Lung Cancer

This phase II trial studies how well talazoparib works in treating patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer that has come back after previous treatment. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Checked against the public recordLast updated Jun 23, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1157
SponsorSWOG Cancer Research Network
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SWOG Cancer Research Network
Interventions being studied
Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Talazoparib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) * Patients must be assigned to S1400G; S1400G biomarker eligibility defined as homologous recombination repair deficiency (HRRD) positive is as follows * Biomarker-positive group * HRRD by FMI * Homologous recombination repair deficiency by Foundation Medicine Inc., criteria * Alteration type * Truncating mutation, frameshift deletions, indels missense and nonsense mutations predicted to have functional consequence in any of the specified genes * Eligible alteration * Mutation in any one of the following critical HRR pathway genes: ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCF, FANCM, NBN (NBS1), PALB2, RAD51, RAD51B (RAD51L1), RAD54L, RPA1 * Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib \[BMN 673\]) as its primary pharmacology * Patients must have achieved stable disease, a partial response, or a complete response at their first disease assessment after initiating first-line platinum-based chemotherapy; patients determined to have progressed (in the opinion of the treating physician) at their first disease assessment are not eligible * Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (BMN 673) (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease); patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis (within 12 months of sub-study registration) * Patients must be able to take oral medications; patients must be able to swallow capsules whole without crushing or altering them in any way * Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors, P-gp inducers, or breast cancer resistance protein (BCRP) inhibitors; the language ?P-gp or BCRP inhibitors or inducers? is reworded to ?strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors? for consistency with the investigator brochure * Patients must agree to have blood specimens submitted for pharmacokinetic analysis

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
  • Anchorage Associates in Radiation MedicineAnchorage, Alaska
  • Anchorage Radiation Therapy CenterAnchorage, Alaska
  • Alaska Breast Care and Surgery LLCAnchorage, Alaska
  • Alaska Oncology and Hematology LLCAnchorage, Alaska
  • Alaska Women's Cancer CareAnchorage, Alaska
  • Anchorage Oncology CentreAnchorage, Alaska
  • Katmai Oncology GroupAnchorage, Alaska
  • Providence Alaska Medical CenterAnchorage, Alaska
  • Fairbanks Memorial HospitalFairbanks, Alaska
  • University of Arizona Cancer Center-Orange Grove CampusTucson, Arizona
  • University of Arizona Cancer Center-North CampusTucson, Arizona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 23, 2021. Always confirm current availability with the study team.

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