Trial Outcomes & Findings for Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer (NCT NCT03237377)

NCT ID: NCT03237377

Last Updated: 2025-10-14

Results Overview

Number of participants experiencing adverse events as defined by CTCAE v4.0.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

3 months post surgery

Results posted on

2025-10-14

Participant Flow

The study was terminated due to low accrual on Arm A (Durvalumab with Radiation) so no participants were assigned to Arm B (Durvalumab and Trememlimumab with Radiation).

Participant milestones

Participant milestones
Measure	Durvalumab With Radiation Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Overall Study STARTED	9	0
Overall Study COMPLETED	9	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants	—	66 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White Non-Hispanic	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White Ethnicity Unknown	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African-American Non-Hispanic	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian Non-Hispanic	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Race/Ethnicity Unknown	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Region of Enrollment Canada	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	—	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post surgery

Population: all participants who were assigned to the durvalumab with radiation arm

Number of participants experiencing adverse events as defined by CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Toxicities as Measured by Number of Participants Experiencing Adverse Events	9 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: The study closed early due to low accrual on Arm A Durvalumab with Radiation so no data was collected for Arm B Durvalumab and Trememlimumab with Radiation.

Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed.

Outcome measures

Outcome measures
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Feasibility of Preoperative Immunoradiation	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 months post-surgery

Population: The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation

Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model. The values in the table represent the number of participants who experienced post-operative death.

Outcome measures

Outcome measures
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Surgical Morbidity and Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation

Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is \>90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated.

Outcome measures

Outcome measures
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Percentage of Participants With Pathologic Response	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation

Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, PD is \>20% increase in sum of diameters of target lesions, SD is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Durvalumab With Radiation n=9 Participants Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Percentage of Participants With Radiologic Response	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Time from first evidence of response until recurrence when treated with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Number of months alive after treatment with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.

Outcome measures

Outcome data not reported

Adverse Events

Durvalumab With Radiation

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Durvalumab and Trememlimumab With Radiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab With Radiation n=9 participants at risk Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery	Durvalumab and Trememlimumab With Radiation Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
Respiratory, thoracic and mediastinal disorders aspiration pneumonia	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Vascular disorders thromboembolic event	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Infections and infestations appendicitis	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Respiratory, thoracic and mediastinal disorders pneumothorax	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Cardiac disorders atrial fibrillation	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Respiratory, thoracic and mediastinal disorders aspiration	11.1% 1/9 • Number of events 2 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Respiratory, thoracic and mediastinal disorders pleural effusion	11.1% 1/9 • Number of events 1 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.	— 0/0 • Post-surgery, up to 3 months. The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.

Other adverse events

Additional Information

Jasmine Brooks, Senior Research Program Coordinator

Johns Hopkins SKCCC CRO Coordinating Center

Phone: 667-306-8335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place