Trial Outcomes & Findings for Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer (NCT NCT04348292)

Last Updated: 2024-08-22

Results Overview

Other adverse events will be listed and summarized by severity, seriousness, and by system organ class. The number and percentage of subjects who experience AEs will be presented in tabular and/or graphical format and summarized descriptively, where appropriate. The frequency of overall toxicity, categorized by toxicity grades 1 through 5, will be described.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

at time of surgery

Results posted on

2024-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sirolimus, Durvalumab) Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sirolimus and Durvalumab for the Treatment of Stage I-IIIA Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sirolimus, Durvalumab) n=3 Participants Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Age, Continuous	70 years STANDARD_DEVIATION 7.23 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of surgery

Outcome measures

Outcome measures
Measure	Treatment (Sirolimus, Durvalumab) n=3 Participants Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	3 Participants

PRIMARY outcome

Timeframe: at time of surgery

Disappearance of all invasive cancer

Outcome measures

Outcome measures
Measure	Treatment (Sirolimus, Durvalumab) n=2 Participants Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Complete Pathologic Response PDL-1 negative	1 Participants
Complete Pathologic Response PDL-1 positive	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at time of surgery

Any number of patients who experienced dose limiting toxicity

Outcome measures

Outcome measures
Measure	Treatment (Sirolimus, Durvalumab) n=3 Participants Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Number of Participants With Dose Limiting Toxicity (DLT)	0 Participants

Adverse Events

Treatment (Sirolimus, Durvalumab)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Sirolimus, Durvalumab) n=3 participants at risk Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery. Durvalumab: Given IV Sirolimus: Given PO
Respiratory, thoracic and mediastinal disorders dyspnea	66.7% 2/3 • Number of events 2 • adverse event data were collected from screening until surgical resection, an average of 12 weeks
General disorders fatigue	33.3% 1/3 • Number of events 1 • adverse event data were collected from screening until surgical resection, an average of 12 weeks
Blood and lymphatic system disorders chyle leak	33.3% 1/3 • Number of events 1 • adverse event data were collected from screening until surgical resection, an average of 12 weeks
Respiratory, thoracic and mediastinal disorders pulmonary fibrosis	33.3% 1/3 • Number of events 1 • adverse event data were collected from screening until surgical resection, an average of 12 weeks

Additional Information

Jennifer Carlisle, MD

Emory University

Phone: 404-778-2304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place