Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
953actual
Sites
210
Countries
Argentina, Brazil, Bulgaria +26
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 | 2015-11-03 | actual | When the study began enrolling |
| Primary completion | 2020-09-21 | 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 | 2015-09-07 | estimated | When this record first appeared on the registry |
| Results posted | 2022-05-24 | 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: 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
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set
measured From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).
OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set
measured From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-01-20 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-05-17 · 639 KB · SAP_001.pdf
Publications
- PMID 36806898 — 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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