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

  • Interventional
  • Recruiting
  • NCT04025879
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

        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 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

        Exclusion Criteria:

         - 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

At a Glance

National Government IDNCT04025879

IRB#IRB19-1921

Lead SponsorBristol-Myers Squibb

Lead PhysicianChristine Bestvina

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting