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Chemotherapy Agent
KEAPSAKE: A Study of Telaglenastat (CB-839) With Standard-of-Care Chemoimmunotherapy in 1L KEAP1/NRF2-Mutated, Nonsquamous NSCLC (KEAPSAKE Trial)
Phase 2
Waitlist Available
Research Sponsored by Calithera Biosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Summary
This trial is testing a new cancer drug compared to the standard of care, to see if it is more effective and has fewer side effects.
Eligible Conditions
- Adenocarcinoma
- Non-Small Cell Lung Cancer
- Gene Mutation
- NRF2 Gene Mutation
- NFE2L2 Gene Mutation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary study objectives
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
Pharmacotherapy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Telaglenastat with Pembrolizumab and ChemotherapyExperimental Treatment7 Interventions
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.
Group II: Placebo with Pembrolizumab and ChemotherapyPlacebo Group7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telaglenastat
2020
Completed Phase 1
~30
Vitamin B12 1000 μg
2016
Completed Phase 3
~660
Dexamethasone 4 mg
2016
Completed Phase 4
~1070
Find a Location
Who is running the clinical trial?
Calithera Biosciences, IncLead Sponsor
33 Previous Clinical Trials
1,981 Total Patients Enrolled
Emil Kuriakose, MDStudy DirectorCalithera Biosciences, Inc
3 Previous Clinical Trials
333 Total Patients Enrolled