NCT03377556

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

A Phase II Study of Talazoparib (BMN 673) in Patients With Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients. SECONDARY OBJECTIVES: I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with therapy in HRRD MDVN-positive patients. II. To evaluate ORR, IA-PFS, and OS in HRRD Foundation Medicine, Inc. (FMI)-positive patients. III. To evaluate ORR in HRRD MDVN-negative/HRRD FMI-positive patients. IV. To evaluate the frequency and severity of toxicities associated with talazoparib (BMN 673) in HRRD FMI-positive patients. TERTIARY OBJECTIVES: I. To assess if the homologous recombination deficiency (HRD) score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib (BMN 673). II. To assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib (BMN 673). III. To characterize pharmacokinetic properties of talazoparib (BMN 673). OUTLINE: Patients receive talazoparib orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and at the end of year 3.

Conditions

• ATM Gene Mutation
• ATR Gene Mutation
• BARD1 Gene Mutation
• BRCA1 Gene Mutation
• BRCA2 Gene Mutation
• BRIP1 Gene Mutation
• CHEK1 Gene Mutation
• CHEK2 Gene Mutation
• FANCA Gene Mutation
• FANCC Gene Mutation
• FANCD2 Gene Mutation
• FANCF Gene Mutation
• FANCM Gene Mutation
• NBN Gene Mutation
• PALB2 Gene Mutation
• RAD51 Gene Mutation
• RAD51B Gene Mutation
• RAD54L Gene Mutation
• Recurrent Squamous Cell Lung Carcinoma
• RPA1 Gene Mutation
• Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Talazoparib	Given PO

Timeline

• Start date: 2017-03-03
• Primary completion: 2021-01-10
• Completion: 2021-04-16
• First posted: 2017-12-19
• Last updated: 2021-06-23
• Results posted: 2021-06-23

Locations

1,157 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study