Last reviewed · How we verify

NCT02087423: ATLANTIC

A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Completed Phase 2 Results posted Last updated 6 April 2026
What this trial tests

Phase 2 trial testing MEDI4736 in Non-Small Cell Lung Cancer in 446 participants. Completed in 26 March 2025.

Timeline
25 February 2014
Primary endpoint
3 June 2016
26 March 2025

Quick facts

Lead sponsorAstraZeneca
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment446
Start date25 February 2014
Primary completion3 June 2016
Estimated completion26 March 2025
Sites139 locations across France, Italy, Japan, Belgium, Austria, Taiwan, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

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 .

GroupValue95% CI
Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)12.25.7 – 21.8
Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)3.60.1 – 18.3
Cohort 2 PD-L1+ (>=25%)16.410.8 – 23.5
Cohort 2 PD-L1+ (<25%)7.53.1 – 14.9
Cohort 3 (TC>=90%)30.920.2 – 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.

GroupValue95% CI
Cohort 2 PD-L1+ (>=25%)1.91.6 – 16.7
Cohort 2 PD-L1+ (<25%)2.11.7 – 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

GroupValue95% CI
Cohort 2 PD-L1+ (>=25%)12.37.5 – 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.

GroupValue95% CI
Cohort 1 (EGFR/ALK+) PD-L1+ (>=25%)13.36.3 – 24.5
Cohort 1 (EGFR/ALK+) PD-L1+ (<25%)9.94.2 – 13.3
Cohort 2 PD-L1+ (>=25%)10.98.6 – 13.6
Cohort 2 PD-L1+ (<25%)9.35.9 – 10.8
Cohort 3 (TC>=90%)13.25.9 – 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)

ReactionSystemCohort 1 (EGFR/ALK+)Cohort 2Cohort 3 (TC >=90%)
PneumoniaInfections and infestations
DyspnoeaRespiratory, thoracic and mediastinal disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
SepsisInfections and infestations
Abdominal painGastrointestinal disorders
FatigueGeneral disorders
Atrial fibrillationCardiac disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
Adrenal insufficiencyEndocrine disorders
DiarrhoeaGastrointestinal disorders
General physical health deteriorationGeneral disorders
PyrexiaGeneral disorders
Infectious pleural effusionInfections and infestations
Respiratory tract infectionInfections and infestations
Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory failureRespiratory, thoracic and mediastinal disorders
Haemolytic anaemiaBlood and lymphatic system disorders
Acute coronary syndromeCardiac disorders
Cardiac failureCardiac disorders
Cardio-respiratory arrestCardiac disorders
Pericardial effusionCardiac disorders
HypopituitarismEndocrine disorders
DysphagiaGastrointestinal disorders
Other adverse events (42 terms — click to expand)

ReactionSystemCohort 1 (EGFR/ALK+)Cohort 2Cohort 3 (TC >=90%)
Decreased appetiteMetabolism and nutrition disorders
FatigueGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
AstheniaGeneral disorders
PyrexiaGeneral disorders
NauseaGastrointestinal disorders
AnaemiaBlood and lymphatic system disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
ConstipationGastrointestinal disorders
VomitingGastrointestinal disorders
PruritusSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
Oedema peripheralGeneral disorders
Back painMusculoskeletal and connective tissue disorders
Weight decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
Productive coughRespiratory, thoracic and mediastinal disorders
HypothyroidismEndocrine disorders
RashSkin and subcutaneous tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
HyperthyroidismEndocrine disorders
Musculoskeletal painMusculoskeletal and connective tissue disorders
AnxietyPsychiatric disorders
InsomniaPsychiatric disorders
Urinary tract infectionInfections and infestations
Gamma-glutamyltransferase increasedInvestigations
Blood alkaline phosphatase increasedInvestigations
HyponatraemiaMetabolism and nutrition disorders
DysphoniaRespiratory, thoracic and mediastinal disorders
HaemoptysisRespiratory, thoracic and mediastinal disorders
Abdominal pain upperGastrointestinal disorders
Viral upper respiratory tract infectionInfections and infestations
Aspartate aminotransferase increasedInvestigations
DizzinessNervous system disorders
Alanine aminotransferase increasedInvestigations
Abdominal painGastrointestinal disorders
Non-cardiac chest painGeneral disorders
PainGeneral disorders
Upper respiratory tract infectionInfections and infestations

Most-reported serious reactions: Pneumonia, Dyspnoea, Pleural effusion, Pneumonitis, Anaemia, Sepsis, Abdominal pain, Fatigue.

Data from ClinicalTrials.gov NCT02087423 adverse events section.

Sponsor's own description

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):

  1. Lung cancer immunotherapy: progress, pitfalls, and promises.
    Lahiri A, Maji A, Potdar PD, Singh N, et al · · 2023 · cited 737× · PMID 36810079 · DOI 10.1186/s12943-023-01740-y
  2. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study.
    Garassino MC, Cho BC, Kim JH, Mazières J, et al · · 2018 · cited 462× · PMID 29545095 · DOI 10.1016/s1470-2045(18)30144-x
  3. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade.
    Zhang Q, Luo J, Wu S, Si H, et al · · 2020 · cited 283× · PMID 32816849 · DOI 10.1158/2159-8290.cd-20-0047
  4. Clinical Pharmacokinetics and Pharmacodynamics of Immune Checkpoint Inhibitors.
    Centanni M, Moes DJAR, Trocóniz IF, Ciccolini J, et al · · 2019 · cited 268× · PMID 30815848 · DOI 10.1007/s40262-019-00748-2
  5. Role of the dynamic tumor microenvironment in controversies regarding immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) with EGFR mutations.
    Lin A, Wei T, Meng H, Luo P, et al · · 2019 · cited 179× · PMID 31526368 · DOI 10.1186/s12943-019-1062-7
  6. The Evolving Role of Immune Checkpoint Inhibitors in Cancer Treatment.
    Pennock GK, Chow LQ. · · 2015 · cited 172× · PMID 26069281 · DOI 10.1634/theoncologist.2014-0422
  7. Current state of immunotherapy for non-small cell lung cancer.
    Malhotra J, Jabbour SK, Aisner J. · · 2017 · cited 147× · PMID 28529902 · DOI 10.21037/tlcr.2017.03.01
  8. Antibodies to watch in 2016.
    Reichert JM. · · 2016 · cited 135× · PMID 26651519 · DOI 10.1080/19420862.2015.1125583

Verify or expand the search:

Other trials of MEDI4736

Trials testing the same drug.

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing