Last reviewed · How we verify
Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer
Phase 2 trial testing Durvalumab in Carcinoma, Non-Small-Cell Lung in 60 participants. Completed in 4 October 2022.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 2 December 2016 |
| Primary completion | 16 September 2020 |
| Estimated completion | 4 October 2022 |
| Sites | 1 location across United States |
Weill Medical College of Cornell University
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
MPR is defined as ≤10% residual viable tumor in the resected specimen.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Durvalumab Monotherapy) | 2 | |
| Arm 2 (Durvalumab Plus SBRT) | 16 |
Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Durvalumab Monotherapy) | 0.67 | 0.50 – 0.84 |
| Arm 2 (Durvalumab Plus SBRT) | 0.80 | 0.66 – 0.94 |
Per 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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Durvalumab Monotherapy) | 0 | |
| Arm 2 (Durvalumab Plus SBRT) | 0 | |
| Arm 1 (Durvalumab Monotherapy) | 1 | |
| Arm 2 (Durvalumab Plus SBRT) | 14 | |
| Arm 1 (Durvalumab Monotherapy) | 3 | |
| Arm 2 (Durvalumab Plus SBRT) | 1 | |
| Arm 1 (Durvalumab Monotherapy) | 2 | |
| Arm 2 (Durvalumab Plus SBRT) | 0 |
Adverse events ≥G3 in both arms with and without possible or probable attribution to study drug and graded according to CTCAE v. 4.0
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 (Durvalumab Monotherapy) | 12 | |
| Arm 2 (Durvalumab Plus SBRT) | 15 |
Time frame: From enrollment to 90 days after the last dose of durvalumab. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1 (Durvalumab Monother… | Arm 2 (Durvalumab Plus SBRT) |
|---|---|---|---|
| Lung infection | Infections and infestations | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Bronchopleural Fistula | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — |
| Stroke | Nervous system disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Cardiopulmonary event | Cardiac disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Hyponatremia | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Anaphylaxis | Immune system disorders | — | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Atrial flutter | Cardiac disorders | — | — |
| Autoimmune hemolytic anemia | Immune system disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Arm 1 (Durvalumab Monother… | Arm 2 (Durvalumab Plus SBRT) |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Lipase increased | Investigations | — | — |
| Hypotension | Vascular disorders | — | — |
| Serum amylase increased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hyperglycemia | Investigations | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — |
| Hyperkalemia | Investigations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Hypoalbuminemia | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Fever | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Chills | General disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Infusion related reaction | General disorders | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Hyperthyroidism | Endocrine disorders | — | — |
| Hyponatremia | Investigations | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Presyncope | Nervous system disorders | — | — |
| Weight loss | Investigations | — | — |
Most-reported serious reactions: Lung infection, Thromboembolic event, Fatigue, Anemia, Bronchopleural Fistula, Dyspnea, Upper gastrointestinal hemorrhage, Pneumonitis.
Data from ClinicalTrials.gov NCT02904954 adverse events section.
The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736) with or without stereotactic body radiation therapy (SBRT) as treatment for stage I (tumors \> 2cm), II, and IIIA non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02904954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing