Trial Outcomes & Findings for Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer (NCT NCT02904954)
NCT ID: NCT02904954
Last Updated: 2023-10-11
Results Overview
MPR is defined as ≤10% residual viable tumor in the resected specimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Durvalumab start date to surgical resection, up to 10 weeks
Results posted on
2023-10-11
Participant Flow
Of 64 enrolled participants, 60 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Arm 1 (Durvalumab Monotherapy)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Neoadjuvant (Preoperative) to Surgery
STARTED
|
30
|
30
|
|
Neoadjuvant (Preoperative) to Surgery
COMPLETED
|
26
|
26
|
|
Neoadjuvant (Preoperative) to Surgery
NOT COMPLETED
|
4
|
4
|
|
Adjuvant Durvalumab
STARTED
|
26
|
26
|
|
Adjuvant Durvalumab
COMPLETED
|
6
|
11
|
|
Adjuvant Durvalumab
NOT COMPLETED
|
20
|
15
|
Reasons for withdrawal
| Measure |
Arm 1 (Durvalumab Monotherapy)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Neoadjuvant (Preoperative) to Surgery
Death
|
1
|
1
|
|
Neoadjuvant (Preoperative) to Surgery
Withdrawal by Subject
|
1
|
0
|
|
Neoadjuvant (Preoperative) to Surgery
Disease progression
|
2
|
3
|
|
Adjuvant Durvalumab
Recurrence
|
2
|
0
|
|
Adjuvant Durvalumab
Adverse Event
|
2
|
6
|
|
Adjuvant Durvalumab
Participant wishes
|
12
|
7
|
|
Adjuvant Durvalumab
Physician Decision
|
2
|
1
|
|
Adjuvant Durvalumab
Slow recovery after chemotherapy
|
1
|
0
|
|
Adjuvant Durvalumab
Death
|
0
|
1
|
|
Adjuvant Durvalumab
Prostate cancer
|
1
|
0
|
Baseline Characteristics
Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Durvalumab start date to surgical resection, up to 10 weeksMPR is defined as ≤10% residual viable tumor in the resected specimen.
Outcome measures
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Number of Subjects With Major Pathological Response (MPR)
|
2 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From date of Durvalumab start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years.Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.
Outcome measures
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Kaplan-Meier Disease-Free Survival Proportion at 2 Years
|
0.67 Proportion of subjects
Interval 0.5 to 0.84
|
0.80 Proportion of subjects
Interval 0.66 to 0.94
|
SECONDARY outcome
Timeframe: Treatment day 1 up to weeks 6-7Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by PET/CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Objective Clinical Response Rate
Partial Response
|
1 Participants
|
14 Participants
|
|
Objective Clinical Response Rate
Progressive Disease
|
3 Participants
|
1 Participants
|
|
Objective Clinical Response Rate
Pseudoprogression
|
2 Participants
|
0 Participants
|
|
Objective Clinical Response Rate
Complete Response
|
0 Participants
|
0 Participants
|
|
Objective Clinical Response Rate
Stable Disease
|
24 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 72 weeksPopulation: All randomized patients
Adverse events ≥G3 in both arms with and without possible or probable attribution to study drug and graded according to CTCAE v. 4.0
Outcome measures
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 Participants
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v. 4.0
|
12 Participants
|
15 Participants
|
Adverse Events
Arm 1 (Durvalumab Monotherapy)
Serious events: 12 serious events
Other events: 29 other events
Deaths: 9 deaths
Arm 2 (Durvalumab Plus SBRT)
Serious events: 15 serious events
Other events: 30 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 participants at risk
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 participants at risk
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Endocrine disorders
Adrenal insufficiency
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Cardiopulmonary event
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Vascular disorders
Thromboembolic event
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Platelet count decreased
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Hyponatremia
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Immune system disorders
Anaphylaxis
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Atrial flutter
|
3.3%
1/30 • Number of events 1 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Immune system disorders
Autoimmune hemolytic anemia
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
General disorders
Fatigue
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Blood and lymphatic system disorders
Heparin induced thrombocytopenia
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
26.7%
8/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Infections and infestations
Surgical wound infection
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Nervous system disorders
Presyncope
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Pericarditis
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Myocardial infarction
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
Other adverse events
| Measure |
Arm 1 (Durvalumab Monotherapy)
n=30 participants at risk
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
|
Arm 2 (Durvalumab Plus SBRT)
n=30 participants at risk
Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively.
Durvalumab: Intravenously
Durvalumab plus SBRT: Intravenously
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
20/30 • From enrollment to 90 days after the last dose of durvalumab
|
70.0%
21/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
General disorders
Fatigue
|
60.0%
18/30 • From enrollment to 90 days after the last dose of durvalumab
|
46.7%
14/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
10/30 • From enrollment to 90 days after the last dose of durvalumab
|
53.3%
16/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
43.3%
13/30 • From enrollment to 90 days after the last dose of durvalumab
|
43.3%
13/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Nausea
|
30.0%
9/30 • From enrollment to 90 days after the last dose of durvalumab
|
36.7%
11/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
10/30 • From enrollment to 90 days after the last dose of durvalumab
|
30.0%
9/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
8/30 • From enrollment to 90 days after the last dose of durvalumab
|
40.0%
12/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Vascular disorders
Hypotension
|
26.7%
8/30 • From enrollment to 90 days after the last dose of durvalumab
|
30.0%
9/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Lipase increased
|
26.7%
8/30 • From enrollment to 90 days after the last dose of durvalumab
|
33.3%
10/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Serum amylase increased
|
20.0%
6/30 • From enrollment to 90 days after the last dose of durvalumab
|
26.7%
8/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
23.3%
7/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
20.0%
6/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Hyperkalemia
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Hyperglycemia
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
23.3%
7/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
General disorders
Fever
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
20.0%
6/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
20.0%
6/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Hypoalbuminemia
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
16.7%
5/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Alkaline phosphatase increased
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
General disorders
Chills
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
General disorders
Infusion related reaction
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
4/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Nervous system disorders
Presyncope
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Weight loss
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Hyponatremia
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
3.3%
1/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
10.0%
3/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Gastrointestinal disorders
Colitis
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
|
Endocrine disorders
Immune related thyroiditis
|
0.00%
0/30 • From enrollment to 90 days after the last dose of durvalumab
|
6.7%
2/30 • From enrollment to 90 days after the last dose of durvalumab
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place