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

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Charlottesville, VA United States
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Virginia Cancer Institute

Richmond, VA United States
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Harrison Medical Center

Bremerton, WA United States
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Saint Elizabeth Hospital

Enumclaw, WA United States
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Saint Francis Hospital

Federal Way, WA United States
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Northwest Cancer Clinic

Kennewick, WA United States
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Saint Clare Hospital

Lakewood, WA United States
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Skagit Valley Hospital

Mount Vernon, WA United States
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Jefferson Healthcare

Port Townsend, WA United States
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Peninsula Cancer Center

Poulsbo, WA United States
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Valley Medical Center

Renton, WA United States
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Legacy Salmon Creek Hospital

Vancouver, WA United States
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United Hospital Center

Bridgeport, WV United States
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Saint Mary's Medical Center

Huntington, WV United States
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Marshfield Clinic-Chippewa Center

Chippewa Falls, WI United States
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Aurora Health Center-Fond du Lac

Fond Du Lac, WI United States
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Aurora Cancer Care-Grafton

Grafton, WI United States
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Aurora BayCare Medical Center

Green Bay, WI United States
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Mercy Health System

Janesville, WI United States
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UW Cancer Center Johnson Creek

Johnson Creek, WI United States
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Holy Family Memorial Hospital

Manitowoc, WI United States
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Marshfield Clinic

Marshfield, WI United States
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Marshfield Medical Center

Marshfield, WI United States
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Community Memorial Hospital

Menomonee Falls, WI United States
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Aurora Cancer Care-Milwaukee

Milwaukee, WI United States
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Aurora Sinai Medical Center

Milwaukee, WI United States
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ProHealth D N Greenwald Center

Mukwonago, WI United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Green Bay Oncology - Oconto Falls

Oconto Falls, WI United States
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Aurora Cancer Care-Racine

Racine, WI United States
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HSHS Saint Nicholas Hospital

Sheboygan, WI United States
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Saint Michael's Hospital

Stevens Point, WI United States
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Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, WI United States
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Saint Clare's Hospital

Weston, WI United States
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Aspirus UW Cancer Center

Wisconsin Rapids, WI United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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PCR Oncology

Arroyo Grande, CA United States
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Kaiser Permanente-Fontana

Fontana, CA United States
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Kaiser Permanente-Fresno

Fresno, CA United States
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Kaiser San Rafael-Gallinas

San Rafael, CA United States
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Kaiser Permanente-Woodland Hills

Woodland Hills, CA United States
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UCHealth Memorial Hospital Central

Colorado Springs, CO United States
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Good Samaritan Medical Center

Lafayette, CO United States
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Summit Cancer Care-Candler

Savannah, GA United States
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AMG Oncology - Naperville

Naperville, IL United States
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Parkview Hospital Randallia

Fort Wayne, IN United States
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Saint Joseph London

London, KY United States
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Medical Center of Baton Rouge

Baton Rouge, LA United States
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Beverly Hospital

Beverly, MA United States
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Addison Gilbert Hospital

Gloucester, MA United States
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Saint Joseph Mercy Canton

Canton, MI United States
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Lakeland Hospital Niles

Niles, MI United States
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Huron Medical Center PC

Port Huron, MI United States
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Cox Cancer Center Branson

Branson, MO United States
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Capital Region Southwest Campus

Jefferson City, MO United States
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Mercy Hospital Joplin

Joplin, MO United States
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Nebraska Medicine-Bellevue

Bellevue, NE United States
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Park Ridge Health

Hendersonville, NC United States
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Indu and Raj Soin Medical Center

Beavercreek, OH United States
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Pottstown Hospital

Pottstown, PA United States
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Sovah Health Martinsville

Martinsville, VA United States
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Shenandoah Oncology PC

Winchester, VA United States
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Duluth Clinic Ashland

Ashland, WI United States
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Ascension Saint Michael's Hospital

Stevens Point, WI United States
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Beaumont Hospital - Farmington Hills

Farmington Hills, MI United States
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Haywood Infusion Center

Clyde, NC United States
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Vidant Oncology-Kinston

Kinston, NC United States
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WVUH-Berkely Medical Center

Martinsburg, WV United States
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Camden Clark Medical Center

Parkersburg, WV United States
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HSHS Sacred Heart Hospital

Eau Claire, WI United States
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