Adults 18 to 130, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
Group
Value
95% CI
Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)
12.2
5.7 – 21.8
Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)
3.6
0.1 – 18.3
Cohort 2 PD-L1+ (>=25%)
16.4
10.8 – 23.5
Cohort 2 PD-L1+ (<25%)
7.5
3.1 – 14.9
Cohort 3 (TC>=90%)
30.9
20.2 – 43.3
Time to Response (TTR)Secondary· Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.
Group
Value
95% CI
Cohort 2 PD-L1+ (>=25%)
1.9
1.6 – 16.7
Cohort 2 PD-L1+ (<25%)
2.1
1.7 – 13.8
Duration of Response (DoR)Secondary· Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC\>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC \<25%); therefore the DoR "number of participants analyzed" field has been
Group
Value
95% CI
Cohort 2 PD-L1+ (>=25%)
12.3
7.5 – NA
Overall Survival (OS)Secondary· From date of first treatment until final DCO (up to approximately 3 years 8 months)
OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.
Group
Value
95% CI
Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)
13.3
6.3 – 24.5
Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)
9.9
4.2 – 13.3
Cohort 2 PD-L1+ (>=25%)
10.9
8.6 – 13.6
Cohort 2 PD-L1+ (<25%)
9.3
5.9 – 10.8
Cohort 3 (TC>=90%)
13.2
5.9 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) observed up until 90 days following discontinuation of durvalumab or until the initiation of the first subsequent anticancer therapy following discontinuation of durvalumab (whichever occurred first)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1 (EGFR/ALK+)
Serious: 18/111 (16%)
Deaths: 70/111
Cohort 2
Serious: 77/265 (29%)
Deaths: 217/265
Cohort 3 (TC >=90%)
Serious: 24/68 (35%)
Deaths: 41/68
Serious adverse events (104 terms)
Reaction
System
Cohort 1 (EGFR/ALK+)
Cohort 2
Cohort 3 (TC >=90%)
Pneumonia
Infections and infestations
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
Sepsis
Infections and infestations
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Fatigue
General disorders
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
Adrenal insufficiency
Endocrine disorders
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
General physical health deterioration
General disorders
—
—
—
Pyrexia
General disorders
—
—
—
Infectious pleural effusion
Infections and infestations
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02546661 — Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer
· Phase 1
· active not recruiting
NCT02669914 — MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
· Phase 2
· terminated
NCT02868632 — Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer
· Phase 1
· withdrawn
NCT02549651 — MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C0
· Phase 1
· completed
NCT02592551 — MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 6 April 2026
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/NCT02087423.