Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
730actual
Sites
183
Countries
Argentina, Belgium, Canada +16
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-09-27 | actual | When the study began enrolling |
| Primary completion | 2024-01-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-23 | estimated | The whole study's end, after follow-up |
| First posted | 2018-10-11 | actual | When this record first appeared on the registry |
| Results posted | 2025-08-01 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-11-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Small Cell Lung Cancer
Interventions
- Drug: Durvalumab — also filed as MEDI4736
- Drug: Tremelimumab
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFDurvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1
measured 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)
measured From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-01-10 · 3.3 MB · Prot_003.pdf
Statistical Analysis Planposted 2023-12-20 · 2.2 MB · SAP_004.pdf
Publications
- PMID 41921748 — linked by the registry
- PMID 40976711 — linked by the registry
- PMID 39268857 — linked by the registry
- PMID 31948903 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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