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

NCT04025879 · tracked via the Priya Life Science Ireland tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2019-11-05

Last updated

2026-08-26

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

NivolumabCarboplatinCisplatinPaclitaxelPemetrexedPlaceboDocetaxel

Nivolumab: Specified dose on specified days

Carboplatin: Specified dose on specified days

Cisplatin: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Placebo: Specified dose on specified days

Docetaxel: Specified dose on specified days

Study summary

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable * No brain metastasis * Treatment-naive for NSCLC (no prior systemic anti-cancer treatment) * Ability to provide surgical or biopsy tumor tissue for biomarkers * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 Exclusion Criteria: * Participants with an active, known or suspected autoimmune disease * Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) * Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC * Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Event-Free Survival (EFS) by BICR — From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death

Trial sites (108)

Facility	City	Region
Local Institution - 0104	Tampa	Florida
Local Institution - 0040	Atlanta	Georgia
Local Institution - 0120	Augusta	Georgia
Local Institution - 0145	Chicago	Illinois
Local Institution - 0078	Chicago	Illinois
Local Institution - 0121	Orland Park	Illinois
Rcca Md Llc	Bethesda	Maryland
Local Institution - 0076	Boston	Massachusetts
Local Institution - 0074	Newton	Massachusetts
Local Institution - 0086	Traverse City	Michigan
Local Institution - 0100	Lebanon	New Hampshire
Local Institution - 0055	Cincinnati	Ohio
Local Institution - 0102	Cleveland	Ohio
Local Institution - 0054	Houston	Texas
Local Institution - 0103	Fredericksburg	Virginia
Local Institution - 0043	Buenos Aires	Buenos Aires
Local Institution - 0032	Ciudad Autonoma Beunos Aires	Buenos Aires
Local Institution - 0031	ABB	Buenos Aires F.D.
Local Institution - 0030	CABA	Argentina
Local Institution - 0020	Sydney	New South Wales
Local Institution - 0033	Heidelberg	Victoria
Local Institution - 0122	Melbourne	Victoria
Local Institution - 0023	North Ballarat	Victoria
Local Institution - 0002	Edegem	Belgium
Local Institution - 0005	Liège	Belgium
Local Institution - 0001	Roeselare	Belgium
Local Institution - 0035	Belo Horizonte	Minas Gerais
Local Institution - 0029	Ijuí	Rio Grande do Sul
Local Institution - 0106	São Paulo	São Paulo
Local Institution - 0036	São Paulo	São Paulo
Local Institution - 0034	São Paulo	São Paulo
Local Institution - 0062	Oshawa	Ontario
Local Institution - 0115	Beijing	Beijing Municipality
Local Institution - 0096	Beijing	BEI
Local Institution - 0137	Fuzhou	Fujian
Local Institution - 0136	Fuzhou	Fujian
Local Institution - 0151	Hubei Sheng	Hubei
Local Institution - 0092	Changsha	Hunan
Local Institution - 0093	Changsha	Hunan
Local Institution - 0091	Changsha	Hunan

+ 68 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04025879 on ClinicalTrials.gov ↗ ← All trials in Ireland