Trials Sponsors Conditions Drugs Pricing

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

Keywords

NSCLCKEAP1NRF2NFE2l2LKB1STK11Next Generation SequencingNGSMutationPembrolizumabPemetrexedCarboplatinRandomizedPlaceboChemotherapyTargeted TherapyTelaglenastatGlutamineGlutaminaseGlutathioneImmunotherapyFront-lineFirst-lineNon-squamousKeytrudaAlimtaGuardant360

Outcome Measures

Primary Outcomes (3)

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

Study Arms (2)

Telaglenastat with Pembrolizumab and Chemotherapy

EXPERIMENTAL

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: TelaglenastatDrug: Carboplatin ChemotherapyDrug: Pemetrexed ChemotherapyBiological: Pembrolizumab ImmunotherapyDietary Supplement: Folic acid 400 -1000 μgDietary Supplement: Vitamin B12 1000 μgDrug: Dexamethasone 4 mg

Placebo with Pembrolizumab and Chemotherapy

PLACEBO COMPARATOR

Interventions

TelaglenastatDrug

Oral Glutaminase Inhibitor

Also known as: CB-839

Telaglenastat with Pembrolizumab and Chemotherapy

Carboplatin ChemotherapyDrug

IV infusion

Also known as: Paraplatin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Calithera Biosciences, Inc
Industrylead

Study Sites (102)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

University of South Alabama - Mitchell Cancer Center

Mobile, Alabama, 36604, United States

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Compassionate Cancer Care

Fountain Valley, California, 92708, United States

St. Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

University of Southern California (USC)

Related Publications (1)

Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
PMID: 39462179DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CB-839CarboplatinPemetrexedpembrolizumabFolic AcidVitamin B 12Dexamethasone

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Officials

Emil Kuriakose, MD
Calithera Biosciences, Inc
STUDY DIRECTOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Randomized, placebo controlled
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

July 24, 2020

Actual (reported)

You may not qualify if:

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)
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
Radiation therapy to the lung \> 30 Gy within 6 months prior to randomization
Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis
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.
Treatment with chronic systemic steroids greater than 10 mg equivalent of prednisone per day
Unstable/inadequate cardiac function, defined as the following:
Myocardial infarction or symptomatic ischemia within 6 months prior to randomization
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)
Congestive heart failure (New York Heart Association class III to IV)
Unable to swallow oral medications
Known sensitivity to any component of the study treatment (pembrolizumab, carboplatin, pemetrexed, and/or telaglenastat) or previous severe hypersensitivity to another monoclonal antibody (mAb)
Unable or unwilling to take folic acid or vitamin B12 supplementation (per pemetrexed label)
Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) as specified in pemetrexed label
+17 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Telaglenastat with Pembrolizumab and Chemotherapy

Placebo with Pembrolizumab and Chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (102)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (7)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Telaglenastat with Pembrolizumab and Chemotherapy

Placebo with Pembrolizumab and Chemotherapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (102)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (7)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations