A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
461actual
Sites
108
Countries
Argentina, Australia, Belgium +19
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 | 2019-11-05 | actual | When the study began enrolling |
| Primary completion | 2023-07-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2019-07-19 | actual | When this record first appeared on the registry |
| Results posted | 2024-07-23 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Carcinoma, Non-Small-Cell Lung
Interventions
- Biological: Nivolumab — also filed as Opdivo, BMS936558
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Placebo
- Drug: Docetaxel
Primary outcome
what the primary-completion date above is the date OFEvent-Free Survival (EFS) by BICR
measured From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2024-02-28 · 1.8 MB · Prot_SAP_000.pdf
Publications
- PMID 42587156 — linked by the registry
- PMID 41507539 — linked by the registry
- PMID 41431434 — linked by the registry
- PMID 38749033 — linked by the registry
- PMID 35858590 — linked by the registry
- PMID 35135810 — 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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