Stopped: Sponsor decision - funding issues
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.
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Investigator-Assessed Overall Response Rate (ORR) Per RECIST v1.1.
Timeframe: 36 months
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths
Timeframe: From the first dose through 28 days after the last dose of sapanisertib (up to a maximum of 124 days).