KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC (KEAPSAKE)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; NRF2 Gene Mutation; NFE2L2 Gene Mutation
• Intervention / Treatment: Drug: Telaglenastat; Drug: Carboplatin Chemotherapy; Drug: Pemetrexed Chemotherapy; Biological: Pembrolizumab Immunotherapy; Dietary supplement: Folic acid 400 -1000 μg; Dietary supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36604
      • University of South Alabama - Mitchell Cancer Center
  • Arizona
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center
  • California
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • Loma Linda, California, United States, 92350
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA
    • Los Angeles, California, United States, 90033
      • University of Southern California (USC)
    • Orange, California, United States, 92868
      • University of California Irvine, Chao Family Comprehensive Cancer Center
    • Santa Rosa, California, United States, 95403
      • St. Joseph Heritage Healthcare - Santa Rosa
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
    • Washington, District of Columbia, United States, 20016
      • Johns Hopkins Sibley Memorial Hospital
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital Lynn Cancer Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital - Bines Cancer Center
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialist - South (SCRI)
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute at Memorial Hospital West
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Comprehensive Cancer Center
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialist - North (SCRI)
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialist - Panhandle (SCRI)
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialist - East (SCRI)
  • Georgia
    • Athens, Georgia, United States, 30607
      • University Cancer and Blood Center
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30318
      • Piedmont Cancer Institute
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Oncology of Northshore
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
    • South Bend, Indiana, United States, 46601
      • Beacon Health
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center (KUMC)
  • Louisiana
    • Covington, Louisiana, United States, 70443
      • Pontchartrain Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Memorial Hospital
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology - USOR
    • Frederick, Maryland, United States, 21702
      • Frederick Health - James M. Stockman Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Cancer Institute
    • Kalamazoo, Michigan, United States, 49001
      • Bronson Methodist Hospital (West Michigan Cancer Center)
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital Cancer Care Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology, P.A.
    • Edina, Minnesota, United States, 55435
      • Minnesota Oncology Hematology, P.A.
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology, P.A.
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A.
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology, P.A.
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology, P.A.
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • New Jersey Cancer Care and Blood Disorders (NJCCBD)
    • Berkeley Heights, New Jersey, United States, 07932
      • Summit Medical Group
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital - Luckow Pavilion
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Comprehensive Cancer Center
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, P.C. (400 Patoon Creek Blvd.)
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, P.C. (43 New Scotland Ave.)
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology, P.C.
    • Mineola, New York, United States, 11501
      • Pelmutter Cancer Center at Winthrop
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical College - New York Presbyterian Hospital
    • New York, New York, United States, 10016
      • New York University Langone (NYU)
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Cone Health at Alamance Regional
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45220
      • TriHealth Cancer Institute
    • Columbus, Ohio, United States, 43214
      • Ohio Health
    • Columbus, Ohio, United States, 43210
      • Ohio State University, James Cancer Hospital and Solove Research Institute
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Cancer Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute (OCSRI)
  • Oregon
    • Portland, Oregon, United States, 92713
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University (OHSU) Knight Cancer Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
    • State College, Pennsylvania, United States, 16801
      • Pennsylvania State University Milton S. Hershey Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Health
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology - Chattanooga (SCRI)
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology - Nashville (SCRI)
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin Midtown
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central
    • Beaumont, Texas, United States, 77701
      • Texas Oncology Beaumont - USOR
    • Denison, Texas, United States, 75020
      • Texas Oncology - Denison
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Houston, Texas, United States, 770390
      • Oncology Consultants
    • Laredo, Texas, United States, 78041
      • Oncology and Hematology of South Texas
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialist
    • Salt Lake City, Utah, United States, 84112
      • University of Utah - Huntsman Cancer Institute
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Oncology and Hematology Associates of Southwest Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
    • Low Moor, Virginia, United States, 24457
      • Oncology and Hematology Associates of Southwest Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University (VCU) Massey Cancer Center
    • Roanoke, Virginia, United States, 24014
      • Oncology and Hematology Associates of Southwest Virginia
    • Salem, Virginia, United States, 24153
      • Oncology and Hematology Associates of Southwest Virginia
    • Wytheville, Virginia, United States, 24382
      • Oncology and Hematology Associates of Southwest Virginia
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington Seattle Cancer Care Alliance (SCCA)
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialities
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Carbone Cancer Center
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and the Medical College of Wisconsin (MCW)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically documented non-squamous NSCLC

2. 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.

3. 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

4. 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

5. Age ≥ 18 years on the day of signing informed consent
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Estimated life expectancy of at least 3 months
8. 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
9. 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.
10. Adequate organ function laboratory findings (defined per protocol)

11. 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

Exclusion Criteria:

1. Squamous cell histology and mixed histology tumors with any small-cell/neuroendocrine component (other mixed histology should be reviewed with the medical monitor for eligibility)
2. Any other concurrent malignancy requiring local or systemic therapy. Patients with other previously treated malignancy(ies) are allowed if the specific neoplasm, in the opinion of the principal investigator and with the agreement of the medical monitor, is not expected to interfere with study-specific endpoints
3. Radiation therapy to the lung > 30 Gy within 6 months prior to randomization
4. Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis

5. Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

   a. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

6. Treatment with chronic systemic steroids greater than 10 mg equivalent of prednisone per day

7. Unstable/inadequate cardiac function, defined as the following:

   1. Myocardial infarction or symptomatic ischemia within 6 months prior to randomization
   2. Uncontrolled or clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with 1st degree atrioventricular [AV] block or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB] are eligible)
   3. Congestive heart failure (New York Heart Association class III to IV)
8. Unable to swallow oral medications
9. Known sensitivity to any component of the study treatment (pembrolizumab, carboplatin, pemetrexed, and/or telaglenastat) or previous severe hypersensitivity to another monoclonal antibody (mAb)
10. Unable or unwilling to take folic acid or vitamin B12 supplementation (per pemetrexed label)
11. Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) as specified in pemetrexed label
12. Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoid treatment
13. Unable or unwilling to discontinue proton pump inhibitor (PPI) use ≥ 5 days prior to randomization
14. Patient known to be positive for Human Immunodeficiency Virus (HIV)
15. Known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hepatitis C antibody result and known quantitative Hepatitis C virus RNA results greater than the lower limits of detection of the assay. Patients receiving antiviral therapy for Hepatitis B or C also are not eligible
16. Any condition including social, psychiatric or medical (including uncontrolled significant concurrent illness) that in the opinion of the Investigator could interfere with treatment or protocol-related procedures
17. Regular use of illicit drugs or history (within past year) of substance abuse (including alcohol)
18. Patients who are pregnant or lactating
19. Major surgery < 3 weeks prior to randomization. In addition, patients with ongoing clinically relevant complications from prior surgery are not eligible and they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
20. Any radiation therapy within 2 weeks prior to randomization (with exception of SRS for brain metastases). In addition, patients with ongoing clinically relevant complications from prior radiation therapy, patients requiring corticosteroids to treat radiation toxicity and patients who developed radiation pneumonitis are not eligible.
21. Symptomatic ascites or pleural effusion. Patients who are clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) are eligible
22. Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption or oral study drug
23. Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to randomization. Anti-infective therapy must be completed at least 7 days before randomization

24. Patients with active and/or untreated central nervous system metastasis including carcinomatous meningitis (leptomeningeal disease) are not eligible. Patients with previously treated brain metastases are eligible if they meet the following criteria:

    1. Received definitive treatment with stereotactic radiosurgery (SRS) or surgery to all known central nervous system (CNS) lesions (whole brain radiotherapy is not an eligible modality)
    2. Be at least 4 weeks post-surgical resection of CNS disease, symptomatically stable and off steroids before randomization
25. Any live-virus vaccination within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist ®) are live attenuated vaccines and are not allowed
26. Has had an allogeneic tissue/solid organ transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Telaglenastat; Oral Glutaminase Inhibitor; Other Names: CB-839; Drug: Carboplatin Chemotherapy; IV infusion; Other Names: Paraplatin; Drug: Pemetrexed Chemotherapy; IV infusion; Other Names: Alimta; Biological: Pembrolizumab Immunotherapy; IV infusion; Other Names: Keytruda; Dietary supplement: Folic acid 400 -1000 μg; Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.; Dietary supplement: Vitamin B12 1000 μg; Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.; Drug: Dexamethasone 4 mg; For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
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.	Drug: Carboplatin Chemotherapy; IV infusion; Other Names: Paraplatin; Drug: Pemetrexed Chemotherapy; IV infusion; Other Names: Alimta; Biological: Pembrolizumab Immunotherapy; IV infusion; Other Names: Keytruda; Dietary supplement: Folic acid 400 -1000 μg; Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.; Dietary supplement: Vitamin B12 1000 μg; Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.; Drug: Dexamethasone 4 mg; For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.; Drug: Placebo; Oral placebo; Other Names: Oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Duration of investigator-determined PFS per RECIST v1.1 in the intent-to-treat (ITT) population	Up to 24 months
Safety and Tolerability of Telaglenastat Plus Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Type, Incidence, Severity, Seriousness, and Study Drug Relatedness of Adverse Events per CTCAE v5.0		Up to 55 months
Recommended Phase 2 Dose of Telaglenastat in Combination with Standard-of-Care Pembrolizumab and Chemotherapy Assessed by Incidence and Nature of Protocol Defined Dose-Limiting Toxicities (DLTs) During the Safety Run-in Period		Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) for Patients Treated with Telaglenastat plus Standard-of-Care Pembrolizumab and Chemotherapy versus Placebo plus Standard-of-Care Pembrolizumab and Chemotherapy	ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria as assessed by the investigator.	Up to 24 months
Duration of Response (DOR) for Patients Treated with Telaglenastat plus Standard-of-Care Pembrolizumab and Chemotherapy versus Placebo plus Standard-of-Care Pembrolizumab and Chemotherapy	DOR is defined as the duration of response for patients achieving a CR or PR	Up to 24 months
Overall Survival		Up to 55 months
PFS in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway		Up to 24 months
ORR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway		Up to 24 months
DOR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway		Up to 24 months
OS in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway		Up to 55 months

Collaborators and Investigators

• Sponsor: Calithera Biosciences, Inc
• Investigators: Study Director: Emil Kuriakose, MD, Calithera Biosciences, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC; Immunotherapy; Randomized; Pembrolizumab; Carboplatin; Chemotherapy; Pemetrexed; Keytruda; KEAP1; Mutation; Glutamine; Placebo; NGS; Glutathione; Next Generation Sequencing; Front-line; Targeted Therapy; Non-squamous; First-line; Glutaminase; STK11; Alimta; NRF2; NFE2l2; LKB1; Telaglenastat; Guardant360
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid Antagonists; Dexamethasone; Carboplatin; Pembrolizumab; Folic Acid; Vitamin B 12; Hydroxocobalamin; Pemetrexed
• Other Study ID Numbers: CX-839-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No