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Chemotherapy Agent

Telaglenastat with Pembrolizumab and Chemotherapy for Non-Small Cell Lung Cancer (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 55 months
Awards & highlights

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
  • Non-Small Cell Lung Cancer
  • Gene Mutation
  • NRF2 Gene Mutation
  • NFE2L2 Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 55 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 55 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS), Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Pharmacotherapy
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
Secondary outcome measures
DOR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway
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
ORR in the Subgroup of Patients with Biochemical Evidence of Activation of the NRF2 Pathway
+4 more

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
~8 spots leftby Sep 2025
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