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


I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients.


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.


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).


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

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Rapid City Regional Hospital

Rapid City, SD United States
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Lowell General Hospital

Lowell, MA United States
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Assarian Cancer Center

Novi, MI United States
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Bryn Mawr Hospital

Bryn Mawr, PA United States
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MetroHealth Medical Center

Cleveland, OH United States
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Reid Health

Richmond, IN United States
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Meharry Medical College

Nashville, TN United States
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Northwest Cancer Clinic

Kennewick, WA United States
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Northside Hospital

Atlanta, GA United States
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Kootenai Cancer Center

Post Falls, ID United States
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Boulder Community Hospital

Boulder, CO United States
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Sinai Hospital of Baltimore

Baltimore, MD United States
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Carle Cancer Center

Urbana, IL United States
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Medical Center of Baton Rouge

Baton Rouge, LA United States
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Baystate Medical Center

Springfield, MA United States
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University of Virginia Cancer Center

Charlottesville, VA United States
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Feather River Cancer Center

Paradise, CA United States
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Saint Francis Medical Center

Cape Girardeau, MO United States
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Saint Joseph Mercy Hospital

Ann Arbor, MI United States
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Hardin Memorial Hospital

Elizabethtown, KY United States
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SIH Cancer Institute

Carterville, IL United States
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Mary Imogene Bassett Hospital

Cooperstown, NY United States
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PCR Oncology

Arroyo Grande, CA United States
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Mills-Peninsula Medical Center

Burlingame, CA United States
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Decatur Memorial Hospital

Decatur, IL United States
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Frederick Memorial Hospital

Frederick, MD United States
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Adena Regional Medical Center

Chillicothe, OH United States
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Mercy Hospital

Coon Rapids, MN United States
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Katmai Oncology Group

Anchorage, AK United States
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Heartland Regional Medical Center

Saint Joseph, MO United States
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Illinois CancerCare-Bloomington

Bloomington, IL United States
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Mercy Health Saint Mary's

Grand Rapids, MI United States
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Roper Hospital

Charleston, SC United States
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Recruitment Status: Open

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