A Phase 3, Randomized, Double blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer
- Conditions
- Non-small cell lung cancer10038666
- Registration Number
- NL-OMON55271
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
• Males and females >= 18 years
• Suspected or histologically confirmed, resectable Stage IIA (>= 4cm) to IIIB
(T3N2) NSCLC with disease that is considered resectable. Staging should be
based on the 8th edition of the AJCC/UICC staging system.
• No brain metastasis
• Participants must be eligible for complete resection and must agree to
undergo standard of care surgery for complete resection of NSCLC after
neoadjuvant therapy
• Treatment-naïve (no prior systemic anti-cancer treatment)
• Eastern Cooperative Oncology Group (ECOG) performance status <= 1
• Ability to provide tumor tissue for biomarker testing
• Women must not be pregnant or breastfeeding
• Non-squamous NSCLC histology with known ALK and EGFR mutation
• Grade >= 2 peripheral neuropathy
• Participants with an active, known or suspected auto-immune disease
• Participants with a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednison equivalent) or other immunosuppresive
medications within 14 days of randomization
• Participants with interstitial lung disease or active, non-infectious
pneumonitis
• Previous malignancies are excluded unless a complete remission was achieved
at least 2 years prior to first treatment an no additional therapy is required
or anticipated during the study
• Positive for active HBV and HCV at screening
• Known history of positive test for HIV or acquired immunodeficiency syndrome
(AIDS) at screening
• Any previous anti-cancer treatment including cytotoxic, IO treatment,
targeted agents or radiotherapy
• History or allergy or hypersensitivity to platinum-containing compounds (if
deemed chemotherapy eligible) or study drug components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>EFS is defined as the length of time from randomization to any of the following<br /><br>events: progression of disease precluding surgery, progression or recurrence of<br /><br>disease after surgery, or death due to any cause. Progression/recurrence will<br /><br>be assessed by BICR per RECIST 1.1.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• OS is defined as the time between the date of randomization and the date of<br /><br>death due to any cause. OS will be censored on the last date a subject was<br /><br>known to be alive.<br /><br><br /><br>• pCR is defined as the number of randomized participants with absence of<br /><br>residual viable tumor in lung and lymph nodes as evaluated by blinded<br /><br>independent pathology review (BIPR), divided by the number of randomized<br /><br>participants for each treatment group.</p><br>