Trial Outcomes & Findings for A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer (NCT NCT05275673)

Last Updated: 2025-04-24

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

36 months

Results posted on

2025-04-24

Participant Flow

This trial was discontinued on 24 Jan 2023 due to limitations in resources. Of approximately 64 participants planned for the study, 7 participants (11%) were enrolled.

Participant milestones

Participant milestones
Measure	Sapanisertib 3 mg QD Sapanisertib 3 mg once daily (QD)	Sapanisertib 2 mg BID Sapanisertib 2 mg twice daily (BID)
Overall Study STARTED	4	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sapanisertib 3 mg QD Sapanisertib 3 mg once daily (QD)	Sapanisertib 2 mg BID Sapanisertib 2 mg twice daily (BID)
Overall Study Study Termination by Sponsor	2	3
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sapanisertib 3 mg QD n=4 Participants Sapanisertib 3 mg orally daily	Sapanisertib 2 mg BID n=3 Participants Sapanisertib 2 mg orally twice daily	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
NFE2L2 Status Participants with NFE2L2-mutated sqNSCLC	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
NFE2L2 Status Participants with NFE2L2-wild type (WT) sqNSCLC	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sapanisertib 3 mg QD n=4 Participants Sapanisertib 3 mg orally daily	Sapanisertib 2 mg BID n=3 Participants Sapanisertib 2 mg orally twice daily
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths AE	3 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths AE >= Grade 3	1 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths Serious AE	1 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths AE Related to Study Drug	3 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Deaths Death	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 6 and 12

Population: 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.

OS is defined as the time from randomization to death due to any cause.

Outcome measures

Outcome data not reported

Adverse Events

Sapanisertib 3 mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Sapanisertib 2 mg BID

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sapanisertib 3 mg QD n=4 participants at risk Sapanisertib 3 mg orally daily	Sapanisertib 2 mg BID n=3 participants at risk Sapanisertib 2 mg orally twice daily
Infections and infestations Sepsis	0.00% 0/4 • 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).	33.3% 1/3 • 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).
Cardiac disorders Cardiac arrest	25.0% 1/4 • 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).	0.00% 0/3 • 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).

Other adverse events

Other adverse events
Measure	Sapanisertib 3 mg QD n=4 participants at risk Sapanisertib 3 mg orally daily	Sapanisertib 2 mg BID n=3 participants at risk Sapanisertib 2 mg orally twice daily
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Gastrointestinal disorders Dental caries	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Gastrointestinal disorders Toothache	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • 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).	33.3% 1/3 • 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).
Infections and infestations Urinary tract infection	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Infections and infestations COVID-19	0.00% 0/4 • 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).	33.3% 1/3 • 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).
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	25.0% 1/4 • 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).	0.00% 0/3 • 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).
Investigations Blood creatinine increased	0.00% 0/4 • 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).	33.3% 1/3 • 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).
Gastrointestinal disorders Nausea	0.00% 0/4 • 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).	33.3% 1/3 • 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).
Infections and infestations Rash pustular	0.00% 0/4 • 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).	33.3% 1/3 • 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).

Additional Information

Medical Monitor

Faeth Therapeutics, Inc

Phone: 7084069282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication by the PI before either a multi-site publication or 18 months after final multi-site study report. PI can only publish their own results and provide 45 days in advance notice. PI must delete any Calithera confidential information from the publication other than study results and give good faith consideration to other comments made by Calithera. The PI must delay the publication for up to 45 days if requested by Calithera and publicly acknowledge Calithera and Pfizer support.
Publication restrictions are in place

Restriction type: OTHER