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mTOR Inhibitor

sapanisertib for Non-Small Cell Lung Cancer

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 36 months
Awards & highlights

Study Summary

This trial is testing a new drug, sapanisertib, for patients with a specific type of lung cancer that has progressed after two other treatments. Patients are split into two groups based on a gene mutation, with one group having the mutation and the other not. The trial will evaluate how well sapanisertib works on its own in patients with this relapsed or refractory cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • NFE2L2 Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Investigator-Assessed Overall Response Rate (ORR) per RECIST v1.1.
Number of Participants With Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Overall Survival (OS) at 12 Months
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group B - NFE2L2 Wild-Type, Dosing Cohort 2Experimental Treatment1 Intervention
sapanisertib 2 mg BID
Group II: Group B - NFE2L2 Wild-Type, Dosing Cohort 1Experimental Treatment1 Intervention
sapanisertib 3 mg QD
Group III: Group A - NFE2L2 Mutation, Dosing Cohort 2Experimental Treatment1 Intervention
sapanisertib 2 mg twice daily (BID)
Group IV: Group A - NFE2L2 Mutation, Dosing Cohort 1Experimental Treatment1 Intervention
sapanisertib 3 mg once daily (QD)

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Who is running the clinical trial?

Calithera Biosciences, IncLead Sponsor
33 Previous Clinical Trials
2,014 Total Patients Enrolled
Bradley J Sumrow, MDStudy DirectorCalithera Biosciences, Inc
~2 spots leftby May 2025
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