18 and older, any sex, with Non-Small Cell Lung Cancer or Squamous Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs), Serious AEs, and DeathsPrimary· From the first dose through 28 days after the last dose of sapanisertib (up to a maximum of 124 days).
An adverse event (AE) is defined as any untoward, undesired, or unplanned medical occurrence in a patient administered a medicinal product whether or not considered drug related. A serious adverse event (SAE) is defined as an AE that occurs after receiving study treatment (or after signing informed consent and before receiving study treatment if due to a protocol-mandated procedure) that either results in death, is life-threatening, requires inpatient hospitalization, results in persistent or significant disability, results in congenital anomaly or birth defect, or otherwise meets criteria as
AE
Group
Value
95% CI
Sapanisertib 3 mg QD
3
Sapanisertib 2 mg BID
2
AE >= Grade 3
Group
Value
95% CI
Sapanisertib 3 mg QD
1
Sapanisertib 2 mg BID
1
Serious AE
Group
Value
95% CI
Sapanisertib 3 mg QD
1
Sapanisertib 2 mg BID
1
AE Related to Study Drug
Group
Value
95% CI
Sapanisertib 3 mg QD
3
Sapanisertib 2 mg BID
1
Death
Group
Value
95% CI
Sapanisertib 3 mg QD
1
Sapanisertib 2 mg BID
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment (all-cause mortality) or from the first dose of study drug (adverse events) through the last day on study (up to a maximum of 124 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Faeth Therapeutics
Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05275673.