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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT04025879

Run by

Bristol-Myers Squibb

People needed

461

Starts

2019-11-05

Expected to finish

2027-07-30

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0040 — Atlanta, Georgia, United States
• Local Institution - 0120 — Augusta, Georgia, United States
• Local Institution - 0145 — Chicago, Illinois, United States
• Local Institution - 0078 — Chicago, Illinois, United States
• Local Institution - 0121 — Orland Park, Illinois, United States
• Rcca Md Llc — Bethesda, Maryland, United States
• Local Institution - 0076 — Boston, Massachusetts, United States
• Local Institution - 0074 — Newton, Massachusetts, United States
• Local Institution - 0086 — Traverse City, Michigan, United States
• Local Institution - 0100 — Lebanon, New Hampshire, United States
• Local Institution - 0055 — Cincinnati, Ohio, United States
• Local Institution - 0102 — Cleveland, Ohio, United States
• Local Institution - 0054 — Houston, Texas, United States
• Local Institution - 0103 — Fredericksburg, Virginia, United States
• Local Institution - 0032 — Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
• Local Institution - 0031 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0043 — Buenos Aires, Argentina
• Local Institution - 0030 — CABA, Argentina
• Local Institution - 0020 — Sydney, New South Wales, Australia
• Local Institution - 0033 — Heidelberg, Victoria, Australia
• Local Institution - 0122 — Melbourne, Victoria, Australia
• Local Institution - 0023 — North Ballarat, Victoria, Australia
• Local Institution - 0002 — Edegem, Belgium
• Local Institution - 0005 — Liège, Belgium
• Local Institution - 0104 — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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