Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,118actual
Sites
196
Countries
Australia, Belgium, Canada +14
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 | 2015-07-21 | actual | When the study began enrolling |
| Primary completion | 2018-10-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2015-05-25 | estimated | When this record first appeared on the registry |
| Results posted | 2019-11-29 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small-Cell Lung Carcinoma NSCLC
Interventions
- Biological: MEDI4736 (Durvalumab)
- Biological: MEDI4736 (Durvalumab)+Tremelimumab
- Drug: Paclitaxel + Carboplatin — also filed as Platinum based Standard of Care Chemotherapy
- Drug: Gemcitabine + Cisplatin — also filed as Platinum based Standard of Care Chemotherapy
- Drug: Gemcitabine + Carboplatin — also filed as Platinum based Standard of Care Chemotherapy
- Drug: Pemetrexed + Cisplatin — also filed as Platinum based Standard of Care Chemotherapy
- Drug: Pemetrexed + Carboplatin — also filed as Platinum based Standard of Care Chemotherapy
- Biological: Tremelimumab
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
measured From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy
measured Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2018-01-09 · 2.1 MB · Prot_015.pdf
Statistical Analysis Planposted 2017-06-20 · 13.0 MB · SAP_000.pdf
Publications
- PMID 33775558 — linked by the registry
- PMID 32271377 — 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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