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.
- Conditions
- Resectable Stage II-IIIB Non-small cell lung cancerMedDRA 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-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 750
- Participants with suspected or histologically confirmed Stage IIA to IIIB 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
- 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
- Primary Outcome Measures
Name Time Method Main Objective: To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A vs Arm B participants;Secondary Objective: - To compare the overall survival (OS) in Arm A vs Arm B participants<br>- To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants<br>- To assess the major pathological response (MPR) rate by BIPR in Arm A vs Arm B participants;Primary end point(s): Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR);Timepoint(s) of evaluation of this end point: 5 Years from randomization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Overall Survival (OS)<br>2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)<br>3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review;Timepoint(s) of evaluation of this end point: 1. Up to 5 years from randomization<br>2. At the time of surgery, between week 12 to week 18<br>3. Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22