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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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)

Do I qualify?Apply below to find out

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has sapanisertib been authorized by the FDA for clinical use?

"As this trial is only in the Phase 2 stage, meaning limited evidence exists on sapanisertib's efficacy and some supporting its safety, a score of 2 was assigned."

Answered by AI

How many participants are eligible for this research endeavor?

"The sponsor, Calithera Biosciences Inc. is looking to recruit 50 suitable participants for the trials located in Fairfax, Virginia and Ocala, Florida."

Answered by AI

How many locations are carrying out the experiment?

"Patients can sign up for this trial at 14 different medical centres, including Virginia Cancer Specialist, PC in Fairfax, Ocala Oncology Center in Ocala, and Florida Cancer Specialists in Fort Myers."

Answered by AI

Are there still openings to participate in this research project?

"Affirmative. Clinicaltrials.gov archives reveal that this medical experiment, which was initially posted online on April 15th 2022, is still actively looking for participants. Fifty volunteers need to be recruited from 14 distinct sites across the country."

Answered by AI

What are the primary aims of this medical research?

"This 36 month-long trial seeks to monitor Number of Patients With Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs. Secondary objectives include Overall Survival (OS), Progression-Free Survival (PFS) and assessing the overall survival rate at 12 months post randomization."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer

2022. "A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05275673.