A Phase 3, Randomized, Double-blind Study of Chemotherapy plusNivolumab versus Chemotherapy plus Placebo provided before surgery,followed by Nivolumab or Placebo provided after surgery for Participantswith Non-small Cell Lung Cancer which can be completely removed bysurgery.
- Conditions
- Resectable Stage II-IIIB Non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502658-15-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
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
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 Tcell co stimulation or checkpoint pathways
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<br>review (BICR) in Arm A vs Arm B participants;Secondary Objective: To compare the overall survival (OS) in Arm A vs Arm B participants, To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants, To assess the major pathological response (MPR) rate by BIPR in Arm A vs Arm B participants, To assess safety and tolerability in Arm A vs Arm B participants;Primary end point(s): Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall Survival (OS);Secondary end point(s):Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR);Secondary end point(s):Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review;Secondary end point(s):Incidence of Serious Adverse Events (SAEs);Secondary end point(s):Incidence of Adverse Events (AEs)