Last updated on September 2018

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03377556

Contact Investigators or Research Sites near you

Start Over

Michigan Cancer Specialists
Roseville, MI United States
  Connect »

Advanced Breast Care Center PLLC
Warren, MI United States
2.44miles
  Connect »

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, MI United States
3.06miles
  Connect »

Macomb Hematology Oncology PC
Warren, MI United States
3.06miles
  Connect »

Michigan Breast Specialists-Warren
Warren, MI United States
3.06miles
  Connect »

Saint John Macomb-Oakland Hospital
Warren, MI United States
3.06miles
  Connect »

Philip J. Stella

Bhadresh Nayak MD PC-Warren
Warren, MI United States
3.06miles
  Connect »

Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, MI United States
5.05miles
  Connect »

Premier Hematology Oncology Care
Sterling Heights, MI United States
5.05miles
  Connect »

Saint John Hospital and Medical Center
Detroit, MI United States
5.61miles
  Connect »

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Lymphoma Clinic of Michigan
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, MI United States
8.18miles
  Connect »

William Beaumont Hospital-Grosse Point
Grosse Pointe, MI United States
8.23miles
  Connect »

Mitchell Folbe MD PC
Sterling Heights, MI United States
8.97miles
  Connect »

Michigan Breast Specialists-Macomb Township
Macomb, MI United States
9.94miles
  Connect »

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, MI United States
9.94miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.