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Clinical Trials in Spain / NCT04025879
Active, not recruiting Phase 3

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 Spain 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)

Nivolumab →Carboplatin →Cisplatin →Paclitaxel →Pemetrexed →PlaceboDocetaxel →

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
No
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)

FacilityCityRegionStatus
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 →

More Bristol-Myers Squibb trials in Spain

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors Recruiting
First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain Active, not recruiting
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas Recruiting
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% Recruiting

Other trials for the same condition

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Active, not recruiting
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib Active, not recruiting
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Active, not recruiting
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 Active, not recruiting
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 Spain