This is a multicenter, randomized, open-label Phase 2 study of sapanisertib in
biomarker-defined populations of sqNSCLC. Patients with NFE2L2 (the name for gene encoding
the protein called NRF2)-mutated or wild-type sqNSCLC should have disease that has progressed
on or after at least two prior systemic therapies for metastatic disease including
platinum-doublet chemotherapy and a programmed cell death 1 ligand 1 (PD-L1) inhibitor. The
study will evaluate sapanisertib monotherapy in patients with relapsed/refractory sqNSCLC as
two separate groups: Group A: NFE2L2-mutated sqNSCLC and Group B: NFE2L2-WT sqNSCLC.
NFE2L2 mutation status for all patients will be identified using local or central next
generation sequencing (NGS) testing on archival or fresh tissue or circulating tumor
deoxyribonucleic acid (ctDNA), the results of which must be reviewed and approved by the
Sponsor prior to enrollment. Each group will be randomized 1:1 to one of two doses/schedules
of sapanisertib. Approximately 30 NFE2L2-mutant and 20 NFE2L2-wild type patients will be
enrolled. Patients will be treated with sapanisertib until disease progression per Response
Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), unacceptable toxicity,
withdrawal of consent, or death.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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