Trial · NCT05275673
A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer
NCT05275673, Phase 2, Terminated, Faeth Therapeutics; results first posted 2025-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer. Trials, record NCT05275673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05275673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer
- NCT number
- NCT05275673
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Faeth Therapeutics
- Conditions
- Non-Small Cell Lung Cancer, Squamous Non-small-cell Lung Cancer, Squamous Non-Small Cell Neoplasm of Lung, NFE2L2 Gene Mutation
- Interventions
- sapanisertib
- First posted
- 2022-03-11
- Last updated
- 2025-04-24
- Results first posted
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-Assessed Overall Response Rate (ORR) Per RECIST v1.1. | 36 months | 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. |
| Primary | Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | 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 an important medical event. Events were categorized as related or not related to study drug, and event severity was graded as mild (1), moderate (2), severe (3), life-threatening (4), or fatal (5). |
| Secondary | Duration of Response (DOR) | 36 months | DOR is the time between the first documentation of partial response (PR) or a complete response (CR) to the first documentation of progressive disease or death, whichever occurs first. |
| Secondary | Progression-Free Survival (PFS) | 36 months | PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) at 6 and 12 Months | Months 6 and 12 | OS is defined as the time from randomization to death due to any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-Assessed Overall Response Rate (ORR) Per RECIST v1.1. | 36 months | No data were collected. No evaluation of efficacy endpoints was performed for this early terminated study, as no participant was enrolled for the planned 36 months. | ||
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | From the first dose through 28 days after the last dose of sapanisertib (up to a maximum of 124 days). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response (DOR) | 36 months | No data were collected. There was no evaluation of efficacy endpoints performed for this early terminated study, as no participant was enrolled for the planned 36 months. | ||
| SECONDARY | Progression-Free Survival (PFS) | 36 months | No data were collected. There was no evaluation of efficacy endpoints performed for this early terminated study, as no participant was enrolled for the planned 36 months. | ||
| SECONDARY | Overall Survival (OS) at 6 and 12 Months | Months 6 and 12 | No data were collected. There was no evaluation of efficacy endpoints performed for this early terminated study, as no participant was enrolled for \>/= 6 months. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 3 mg QD | AE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 2 mg BID | AE | 2 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 3 mg QD | AE >= Grade 3 | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 2 mg BID | AE >= Grade 3 | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 3 mg QD | Serious AE | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 2 mg BID | Serious AE | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 3 mg QD | AE Related to Study Drug | 3 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 2 mg BID | AE Related to Study Drug | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 3 mg QD | Death | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths | Sapanisertib 2 mg BID | Death | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sapanisertib 3 mg QD | 4 | |
| Overall Study | STARTED | Sapanisertib 2 mg BID | 3 | |
| Overall Study | COMPLETED | Sapanisertib 3 mg QD | 0 | |
| Overall Study | COMPLETED | Sapanisertib 2 mg BID | 0 | |
| Overall Study | NOT COMPLETED | Sapanisertib 3 mg QD | 4 | |
| Overall Study | NOT COMPLETED | Sapanisertib 2 mg BID | 3 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Sapanisertib 3 mg QD | 1 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Sapanisertib 2 mg BID | 0 | 3 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Sapanisertib 3 mg QD | 1 | 4 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Sapanisertib 2 mg BID | 0 | 3 | |
| other | Dental caries | Gastrointestinal disorders | Sapanisertib 3 mg QD | 1 | 4 | |
| other | Dental caries | Gastrointestinal disorders | Sapanisertib 2 mg BID | 0 | 3 | |
| other | Toothache | Gastrointestinal disorders | Sapanisertib 3 mg QD | 1 | 4 | |
| other | Toothache | Gastrointestinal disorders | Sapanisertib 2 mg BID | 0 | 3 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Sapanisertib 3 mg QD | 1 | 4 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Sapanisertib 2 mg BID | 1 | 3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sapanisertib 3 mg QD | 1 | 4 |
| Total, all-cause mortality | Sapanisertib 2 mg BID | 0 | 3 |
| Total, other adverse events | Sapanisertib 3 mg QD | 3 | 4 |
| Total, other adverse events | Sapanisertib 2 mg BID | 2 | 3 |
| Total, serious adverse events | Sapanisertib 3 mg QD | 1 | 4 |
| Total, serious adverse events | Sapanisertib 2 mg BID | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sapanisertib 3 mg QD vs Sapanisertib 2 mg BID: deaths from any cause | Trial comparisons |
| Sapanisertib 3 mg QD vs Sapanisertib 2 mg BID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05275673
GET https://conductscience.org/api/trials/v1/NCT05275673/events?page=2