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

NCT02998528

Description:

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. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
  • Official Title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Clinical Trial IDs

  • ORG STUDY ID: CA209-816
  • SECONDARY ID: 2016-003536-21
  • NCT ID: NCT02998528

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoNivolumab plus Ipilimumab
ipilimumabBMS-734016, YervoyNivolumab plus Ipilimumab
cisplatinPlatinum doublet chemotherapy
vinorelbinePlatinum doublet chemotherapy
gemcitabinePlatinum doublet chemotherapy
docetaxelPlatinum doublet chemotherapy
pemetrexedPlatinum doublet chemotherapy
carboplatinPlatinum doublet chemotherapy

Purpose

The purpose of this study is to determine the safety and effectiveness of nivolumab plus ipilimumab or nivolumab plus chemotherapy compared to chemotherapy alone in the treatment of Early Stage Non-Small Cell Lung This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached September 2020. The completion date for all primary outcome measures is expected May 2023.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab plus IpilimumabExperimentalSpecified dose on specified days
    Platinum doublet chemotherapyActive ComparatorSpecified dose on specified days
    • cisplatin
    • vinorelbine
    • gemcitabine
    • docetaxel
    • pemetrexed
    • carboplatin
    Nivolumab plus platinum doublet chemotherapyExperimentalSpecified dose on specified days
    • cisplatin
    • gemcitabine
    • pemetrexed
    • carboplatin

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Event-Free Survival
    Time Frame:Up to 133 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to approximately 193 months
    Safety Issue:
    Description:
    Measure:Major pathological response (MPR)
    Time Frame:At time of surgery
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated

    March 6, 2018