A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.

Phase 1

• Conditions: Resectable Stage II-IIIB Non-small cell lung cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000262-38-RO
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 750

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 (no prior systemic anti-cancer treatment)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
- Ability to provide surgical or biopsy tumor tissue for biomarkers

Other protocol defined inclusion/exclusion criteria could apply

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

- Participants with an active, known or suspected autoimmune disease are excluded
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy

Other protocol defined inclusion/exclusion criteria could apply

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified