A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat With Pembrolizumab and Chemotherapy Versus Placebo With Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)

Who is this study for? Patients with KEAP1/NRF2-mutated, stage IV, nonsquamous, non-small cell lung cancer
Status: Terminated
Location: See all (102) locations...
Intervention Type: Drug, Dietary Supplement, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2, randomized, multicenter, double-blind study of the glutaminase inhibitor telaglenastat with standard-of-care pembrolizumab and chemotherapy versus placebo with standard-of-care pembrolizumab and chemotherapy for first line treatment of metastatic disease in patients with KEAP1/NRF2-mutated, stage IV, nonsquamous, non-small cell lung cancer (NSCLC). The study primary endpoints are PFS per RECIST v. 1.1 and safety. KEAP1/NRF2 mutation status (for eligibility) and STK11/LKB1 status (for stratification) will be determined by next generation sequencing. A commercial liquid biopsy (circulating tumor DNA) NGS test will be provided to study participants free of charge.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically or cytologically documented non-squamous NSCLC

• Stage IV (M1a-c, AJCC 8th Edition, Amin 2017) disease not previously treated with systemic therapy for metastatic NSCLC

• a. Patients who received adjuvant or neo-adjuvant therapy (with or without immunotherapy) for localized NSCLC are eligible if all adjuvant/neo-adjuvant therapy (including immunotherapy) was completed at least 6 months prior to the development of metastatic disease.

• No known actionable mutation in EGFR, ALK, ROS1, BRAF, NTRK or other known actionable mutation for which there is approved therapy in the first-line lung cancer setting

• Must have at least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI)

• a. Target lesions situated in a previously irradiated area may be considered measurable if progression has been demonstrated subsequent to radiation therapy

• Age ≥ 18 years on the day of signing informed consent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Estimated life expectancy of at least 3 months

• Recovery to baseline or ≤ grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to the prior treatment, unless after discussion with the medical monitor, the AE(s) are deemed clinically non-significant and/or stable on supportive therapy

• Has sponsor-approved eligible mutation in KEAP1 or NRF2 documented by NGS from a CAP-accredited and/or CLIA-certified laboratory (study-provided NGS or other NGS) and STK11 mutation status is known for the purpose of stratification.

• Adequate organ function laboratory findings (defined per protocol)

• Reproductive status:

• a. A female patient of childbearing potential must: i. Have a negative serum pregnancy test within 7 days prior to randomization ii. Agree to use methods of contraception outlined in Section 8.1.2 during the study through 120 days following the last dose of telaglenastat or pembrolizumab, or through 180 days following the last dose of chemotherapeutic drugs iii. Postmenopausal females (no menses for > 1 year without an alternate medical cause) and surgically sterilized females are exempt from these requirements b. Male patients who are sexually active with heterosexual partners of childbearing potential must agree to contraceptive requirements outlined in Section 8.1.2 and refrain from donating sperm during the study through 120 days following the last dose of telaglenastat or pembrolizumab, or through 180 days following the last dose of chemotherapeutic drugs

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
University of South Alabama - Mitchell Cancer Center
Mobile
Arizona
Yuma Regional Medical Center
Yuma
California
Compassionate Cancer Care
Fountain Valley
St. Joseph Heritage Healthcare
Fullerton
Loma Linda University Medical Center
Loma Linda
Cedars-Sinai Medical Center
Los Angeles
UCLA
Los Angeles
University of Southern California (USC)
Los Angeles
University of California Irvine, Chao Family Comprehensive Cancer Center
Orange
St. Joseph Heritage Healthcare - Santa Rosa
Santa Rosa
Washington, D.c.
Johns Hopkins Sibley Memorial Hospital
Washington
Sibley Memorial Hospital
Washington
Florida
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton
Holy Cross Hospital - Bines Cancer Center
Fort Lauderdale
Florida Cancer Specialist - South (SCRI)
Fort Myers
Memorial Cancer Institute at Memorial Hospital West
Hollywood
University of Miami Sylvester Comprehensive Cancer Center
Miami
Ocala Oncology Center
Ocala
Florida Cancer Specialist - North (SCRI)
Saint Petersburg
Florida Cancer Specialist - Panhandle (SCRI)
Tallahassee
Moffitt Cancer Center
Tampa
Florida Cancer Specialist - East (SCRI)
West Palm Beach
Georgia
University Cancer and Blood Center
Athens
Emory University Hospital
Atlanta
Piedmont Cancer Institute
Atlanta
Northwest Georgia Oncology
Marietta
Hawaii
Hawaii Cancer Care
Honolulu
Illinois
Oncology of Northshore
Rolling Meadows
Orchard Healthcare Research Inc.
Skokie
Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Beacon Health
South Bend
Kansas
University of Kansas Medical Center (KUMC)
Westwood
Louisiana
Pontchartrain Cancer Center
Covington
Massachusetts
Massachusetts General Hospital
Boston
Maryland
Johns Hopkins Bayview Memorial Hospital
Baltimore
Center for Cancer and Blood Disorders
Bethesda
Maryland Oncology Hematology - USOR
Columbia
Frederick Health - James M. Stockman Cancer Institute
Frederick
Michigan
Henry Ford Cancer Institute
Detroit
Bronson Methodist Hospital (West Michigan Cancer Center)
Kalamazoo
St. Joseph Mercy Hospital Cancer Care Center
Ypsilanti
Minnesota
Minnesota Oncology Hematology, P.A.
Coon Rapids
Minnesota Oncology Hematology, P.A.
Edina
Minnesota Oncology Hematology, P.A.
Maplewood
Minnesota Oncology Hematology, P.A.
Minneapolis
Minnesota Oncology Hematology, P.A.
Saint Paul
Minnesota Oncology Hematology, P.A.
Woodbury
Missouri
Central Care Cancer Center
Bolivar
Washington University
Saint Louis
North Carolina
Cone Health at Alamance Regional
Burlington
Cone Health Cancer Center
Greensboro
Nebraska
Nebraska Methodist Hospital
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New Jersey
New Jersey Cancer Care and Blood Disorders (NJCCBD)
Belleville
Summit Medical Group
Berkeley Heights
The Valley Hospital - Luckow Pavilion
Paramus
New Mexico
University of New Mexico Comprehensive Cancer Center
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.)
Albany
New York Oncology Hematology, P.C. (43 New Scotland Ave.)
Albany
Roswell Park Comprehensive Cancer Center
Buffalo
New York Oncology Hematology, P.C.
Clifton Park
Pelmutter Cancer Center at Winthrop
Mineola
Columbia University Medical Center
New York
Memorial Sloan Kettering Cancer Center
New York
New York University Langone (NYU)
New York
Weill Cornell Medical College - New York Presbyterian Hospital
New York
Ohio
Aultman Hospital
Canton
TriHealth Cancer Institute
Cincinnati
Ohio Health
Columbus
Ohio State University, James Cancer Hospital and Solove Research Institute
Columbus
Toledo Clinic Cancer Center
Toledo
Oklahoma
Oklahoma Cancer Specialists and Research Institute (OCSRI)
Tulsa
Oregon
Oregon Health & Science University (OHSU) Knight Cancer Institute
Portland
Providence Portland Medical Center
Portland
Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh
Pennsylvania State University Milton S. Hershey Medical Center
State College
South Dakota
Sanford Health
Sioux Falls
Tennessee
Tennessee Oncology - Chattanooga (SCRI)
Chattanooga
Tennessee Oncology - Nashville (SCRI)
Nashville
Texas
Texas Oncology - Austin Central
Austin
Texas Oncology - Austin Midtown
Austin
Texas Oncology - South Austin
Austin
Texas Oncology Beaumont - USOR
Beaumont
Texas Oncology - Denison
Denison
Texas Oncology - Fort Worth Cancer Center
Fort Worth
Oncology Consultants
Houston
Oncology and Hematology of South Texas
Laredo
Utah
University of Utah - Huntsman Cancer Institute
Salt Lake City
Utah Cancer Specialist
Salt Lake City
Virginia
Oncology and Hematology Associates of Southwest Virginia
Blacksburg
Virginia Cancer Specialists
Fairfax
Oncology and Hematology Associates of Southwest Virginia
Low Moor
Virginia Commonwealth University (VCU) Massey Cancer Center
Richmond
Oncology and Hematology Associates of Southwest Virginia
Roanoke
Oncology and Hematology Associates of Southwest Virginia
Salem
Oncology and Hematology Associates of Southwest Virginia
Wytheville
Washington
University of Washington Seattle Cancer Care Alliance (SCCA)
Seattle
Northwest Medical Specialities
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Froedtert Hospital and the Medical College of Wisconsin (MCW)
Milwaukee
Time Frame
Start Date: July 24, 2020
Completion Date: February 9, 2022
Participants
Target number of participants: 40
Treatments
Experimental: Telaglenastat with Pembrolizumab and Chemotherapy
The glutaminase inhibitor telaglenastat will be administered orally, twice daily with food, every day in combination with standard-of-care pembrolizumab plus chemotherapy by intravenous (IV) infusion every 3 weeks.
Placebo Comparator: Placebo with Pembrolizumab and Chemotherapy
Placebo will be administered orally twice daily with food every day in combination with standard-of-care pembrolizumab plus chemotherapy by IV infusion every 3 weeks.
Sponsors
Leads: Calithera Biosciences, Inc

This content was sourced from clinicaltrials.gov

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