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NCT05275673 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Faeth Therapeutics.

Terminated
Registry status
Phase 2
Development phase
7
Enrollment target

NCT05275673: Clinical Trial Phase 2 study, sponsored by Faeth Therapeutics.

NCT05275673 is a Phase 2 study that was terminated before completion, run by Faeth Therapeutics. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05275673, a Phase 2 study, was terminated before completion, sponsored by Faeth Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

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.

Primary Outcome

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria as assessed by the investigator.

Interventions

  • DRUG sapanisertib

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2022-07-21
Est. Completion 2023-01-24
Phase Phase 2
Faeth Therapeutics

5 total trials

Why NCT05275673 stopped before completion

NCT05275673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which sapanisertib is the first listed.

NCT05275673 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05275673 about?

NCT05275673 is a clinical study titled "A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer". 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 syste...

What is the current status of trial NCT05275673?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2022-07-21. Estimated completion is 2023-01-24.

What interventions are being tested in trial NCT05275673?

The interventions under investigation include: sapanisertib (DRUG).

Who is sponsoring clinical trial NCT05275673?

This trial is sponsored by Faeth Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05275673's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05275673, the US trial registry maintained by the National Library of Medicine. NCT05275673 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.