Trial Outcomes & Findings for Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer (NCT NCT04560686)

Results Overview

MPR will be defined as =\< 10% viable tumor cells in the resected specimen using the methods described by Pataer et al. Will estimate the MPR rate with a 95% credible interval (CI) assuming that the MPR rate follows a prior beta distribution (0.5, 0.5) with one patient worth of information.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

At time of surgery

Results posted on

2022-07-28

Participant Flow

Participants with stage I- IIIA NSCLC amenable for surgical resection were enrolled to this study in the Thoracic Medical Oncology Center at MD Anderson Cancer Center.

Two participants were consented; one screen failure. The trial was terminated earlier than planned due to an administrative decision taken by the PI/co-PI in collaboration with the study sponsor based on emerging data made available with the investigational agent being tested in other diseases in the perioperative setting.

Participant milestones

Participant milestones
Measure	Arm A: M7824 , Surgery, SOC Post-Op M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: M7824 , Surgery, SOC Post-Op n=1 Participants M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 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	1 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
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery

Population: Data were not collected.

MPR will be defined as =\< 10% viable tumor cells in the resected specimen using the methods described by Pataer et al. Will estimate the MPR rate with a 95% credible interval (CI) assuming that the MPR rate follows a prior beta distribution (0.5, 0.5) with one patient worth of information.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Data were not collected.

Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Outcome measures

Outcome data not reported

Timeframe: At time of surgery

Complete resection (R0) rate is defined as number of Participants that successfully underwent surgical resection with microscopically clear surgical margins.

Outcome measures

Outcome measures
Measure	Arm A: M7824 , Surgery, SOC Post-Op n=1 Participants M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Complete Resection (RO) Rate	0 Participants

SECONDARY outcome

Timeframe: At time of surgery

Pathologic complete response (pCR) in resected tumor specimens. pCR is defined as the absence of any viable residual tumor at the time of surgical resection in the primary lung lesion and lymph nodes, by central (core) pathology review.

Outcome measures

Outcome measures
Measure	Arm A: M7824 , Surgery, SOC Post-Op n=1 Participants M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Number of Participants With Pathologic Complete Response	0 Participants

SECONDARY outcome

Timeframe: At time of surgery

Population: Due to Early termination of study no analysis was completed.

Quantification of CD8+ TILs will be assessed by counting the cells positive for staining with an anti-CD8 antibody by immunohistochemistry and/or immunofluorescence in five random square areas (1 mm\^2 each) in both intratumoral and peritumoral compartments using an automated system.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years post-treatment

Multivariate analysis will be used to explore the role of biomarkers in predicting pathologic response to treatment, in an exploratory way.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: M7824 , Surgery, SOC Post-Op

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: M7824 , Surgery, SOC Post-Op n=1 participants at risk M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Respiratory, thoracic and mediastinal disorders Pneumothorax	100.0% 1/1 • Number of events 1 • from the time of the first protocol-specific intervention, until 100 days after the last dose of drug, unless the participant withdraws consent, approximately 11 months

Other adverse events

Other adverse events
Measure	Arm A: M7824 , Surgery, SOC Post-Op n=1 participants at risk M7824 1200 mg Q2 Weeks on D1, D15, \& D29 followed by surgery, then possible SOC as post operative therapy
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Number of events 1 • from the time of the first protocol-specific intervention, until 100 days after the last dose of drug, unless the participant withdraws consent, approximately 11 months
Musculoskeletal and connective tissue disorders Bone pain	100.0% 1/1 • Number of events 1 • from the time of the first protocol-specific intervention, until 100 days after the last dose of drug, unless the participant withdraws consent, approximately 11 months
Injury, poisoning and procedural complications Fall	100.0% 1/1 • Number of events 1 • from the time of the first protocol-specific intervention, until 100 days after the last dose of drug, unless the participant withdraws consent, approximately 11 months

Additional Information

Dr. Tina Cascone,MD- Assistant Professor, Thoracic-Head & Neck Med Onc

UT MD Anderson Cancer Center

Phone: (713) 792-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place