A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

  • Interventional
  • Not Recruiting
  • NCT02998528
Eligibility Details Visit Clinicaltrials.gov

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

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:

         - Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

         - Lung function capacity capable of tolerating the proposed lung surgery

         - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

         - Available tissue of primary lung tumor

        Exclusion Criteria:

         - Presence of locally advanced, inoperable or metastatic disease

         - Participants with active, known or suspected autoimmune disease

         - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT02998528

IRB#IRB16-1608

Lead SponsorBristol-Myers Squibb

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting