Trial Outcomes & Findings for Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer (NCT NCT02417701)

Last Updated: 2022-04-05

Results Overview

Overall response rate (CR+PR) will be calculated separately for each cohort, including exact 95% confidence intervals. Duration of overall response and duration of stable disease will be calculated and summarized. Overall response rate was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

CT imaging was obtained after every 2 cycles, or 8 weeks, starting from cycle 1 day 1 until end of study treatment, up to 1 year.

Results posted on

2022-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sapanisertib) Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sapanisertib: Given PO
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sapanisertib) n=34 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sapanisertib: Given PO
Age, Continuous	68.52 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants
Race (NIH/OMB) White	24 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	34 Participants n=99 Participants

PRIMARY outcome

Timeframe: CT imaging was obtained after every 2 cycles, or 8 weeks, starting from cycle 1 day 1 until end of study treatment, up to 1 year.

Population: The number of participants analyzed for ORR is the response evaluable cohort as defined by the protocol, which is a subset of the total study population reflected in the participant flow module.

Outcome measures

Outcome measures
Measure	NFEL2 Squamous Cohort n=12 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	KEAP1 Squamous Cohort n=6 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	KRAS/NFE2L2 or KEAP1 NSCLC Cohort n=6 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate (Complete Response [CR] + Partial Response [PR]) ORR: Complete Response + Partial Response	3 Participants	1 Participants	0 Participants
Objective Response Rate (Complete Response [CR] + Partial Response [PR]) No ORR	9 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: From start of treatment (cycle 1 day 1) until the date of first documented progression or death, over the trial enrollment period, up to 1 year.

Population: PFS in the secondary outcome section is the response evaluable cohort, which is a subset of the total study population.

Median progression-free survival will be estimated using the Kaplan-Meier method with a two-sided 95% confidence interval. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a unequivocal increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	NFEL2 Squamous Cohort n=12 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	KEAP1 Squamous Cohort n=6 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	KRAS/NFE2L2 or KEAP1 NSCLC Cohort n=6 Participants Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	8.9 months Interval 5.6 to Upper limit was not reached due to insufficient number of participants with events	3.7 months Interval 1.8 to Upper limit was not reached due to insufficient number of participants with events	2.1 months Interval 1.6 to Upper limit was not reached due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to week 2

Population: Data were not collected

Single target signaling changes will be reported as percentages relative to the baseline pre-treatment tumor sample. Larger scale pathway changes will qualitatively represented through heatmaps.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Sapanisertib)

Serious events: 8 serious events

Other events: 30 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sapanisertib) n=34 participants at risk Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sapanisertib: Given PO
Gastrointestinal disorders Diarrhea	8.8% 3/34 • Up to 1 year
Metabolism and nutrition disorders Anorexia	5.9% 2/34 • Up to 1 year
Metabolism and nutrition disorders Dehydration	8.8% 3/34 • Up to 1 year
Metabolism and nutrition disorders Hyperglycemia	8.8% 3/34 • Up to 1 year
Vascular disorders Thromboembolic event	8.8% 3/34 • Up to 1 year
Investigations Creatinine Increased	5.9% 2/34 • Up to 1 year
Gastrointestinal disorders Mucositis	8.8% 3/34 • Up to 1 year

Other adverse events

Other adverse events
Measure	Treatment (Sapanisertib) n=34 participants at risk Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Sapanisertib: Given PO
Metabolism and nutrition disorders Hyperglycemia	61.8% 21/34 • Up to 1 year
General disorders Fatigue	32.4% 11/34 • Up to 1 year
Gastrointestinal disorders Diarrhea	29.4% 10/34 • Up to 1 year
Metabolism and nutrition disorders Anorexia	26.5% 9/34 • Up to 1 year
Skin and subcutaneous tissue disorders Rash maculo-papular	23.5% 8/34 • Up to 1 year
Investigations Weight loss	23.5% 8/34 • Up to 1 year
Gastrointestinal disorders Mucositis oral	17.6% 6/34 • Up to 1 year
Gastrointestinal disorders Nausea	17.6% 6/34 • Up to 1 year
Skin and subcutaneous tissue disorders Pruritus	17.6% 6/34 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Cough	14.7% 5/34 • Up to 1 year
Skin and subcutaneous tissue disorders Dry skin	14.7% 5/34 • Up to 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	14.7% 5/34 • Up to 1 year
Gastrointestinal disorders Vomiting	14.7% 5/34 • Up to 1 year
Metabolism and nutrition disorders Hypertriglyceridemia	14.7% 5/34 • Up to 1 year
Investigations Platelet count decreased	14.7% 5/34 • Up to 1 year
Investigations Cholesterol high	8.8% 3/34 • Up to 1 year
Gastrointestinal disorders Flatulence	8.8% 3/34 • Up to 1 year

Additional Information

Dr. Paul Paik, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-608-3759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60