Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

NCT03703297 · ADRIATIC Phase 3Active, not recruiting

Lead sponsor: AstraZeneca (Industry)
Enrollment: 730 (actual)
Start date: 27 Sep 2018
Primary completion: 15 Jan 2024 (actual)
Study completion: 23 Oct 2026
Last update posted: 21 Nov 2025

Design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel
Masking: Triple
Arms: 3

Interventions

Durvalumab Drug
Tremelimumab Drug
Placebo Other

Conditions and primary outcome

Small Cell Lung Cancer

Primary outcome

Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)); Durvalumab Versus Placebo: Overall Survival (OS) (From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03703297 (opens in a new tab)· Licence: public-domain

First posted 1 Aug 2025 · Last update posted 21 Nov 2025 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame
Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
Measure
Median
Unit
months
- Durvalumab vs PlaceboSuperiority
  Estimate
  0.76Hazard Ratio (HR)
  95% CI, two-sided
  0.606 to 0.950
  p-value
  0.01608
  Method
  Log Rank
Durvalumab Versus Placebo: Overall Survival (OS)
Time frame
From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
Measure
Median
Unit
months
- Durvalumab vs PlaceboSuperiority
  Estimate
  0.73Hazard Ratio (HR)
  95% CI, two-sided
  0.569 to 0.928
  p-value
  0.01042
  Method
  Log Rank

Serious adverse events

Time frame: From first dose of study drug(Day 1)upto DCO date 15 January 2024(maximum of approximately 1936 days).Safety population:all participants who received at least 1 dose of study drug.Based on results of secondary objectives at interim analysis(reviewed by unblinded IDMC),data for D+T arm were to remain blinded to Sponsor as pre-specified in study's unblinding plan.Since D+T arm was blinded at time of posting results from this interim analysis,results for that arm will be posted at final analysis.

Participants with serious adverse events per group for ADRIATIC, as posted
Group	Affected	At risk
Durvalumab	78	262
Durvalumab Plus Tremelimumab	0	0
Placebo	64	265

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

5 on PubMed

Population Pharmacokinetics and Exposure-response Analysis of Durvalumab in Patients with Limited-stage Small-cell Lung Cancer in the Phase 3 ADRIATIC Study.
The AAPS journal · 2026 Sep 28
PubMed 42806195 (opens in a new tab)DOI 10.1208/s12248-026-01295-y (opens in a new tab)
Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic Cranial Irradiation in the Phase 3 ADRIATIC Trial.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026 Aug
PubMed 41921748 (opens in a new tab)DOI 10.1016/j.jtho.2026.103703 (opens in a new tab)
Durvalumab Post Concurrent Chemoradiotherapy in Japanese Patients With Limited-Stage Small-Cell Lung Cancer in the Phase 3 ADRIATIC Trial.
Cancer science · 2025 Nov
PubMed 40976711 (opens in a new tab)DOI 10.1111/cas.70188 (opens in a new tab)
Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer.
The New England journal of medicine · 2024 Oct 10
PubMed 39268857 (opens in a new tab)DOI 10.1056/NEJMoa2404873 (opens in a new tab)
Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study.
Clinical lung cancer · 2020 Mar
PubMed 31948903 (opens in a new tab)DOI 10.1016/j.cllc.2019.12.006 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Tremelimumab

Source

NCT03703297 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.