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An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826

Description:

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
  • Official Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CA209-227
  • SECONDARY ID: 2014-003630-23
  • NCT ID: NCT02477826

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivoArm A: Nivolumab
IpilimumabYervoyArm B: Nivolumab + Ipilimumab
CarboplatinArm C: Nivolumab + Platinum doublet chemotherapy
CisplatinArm C: Nivolumab + Platinum doublet chemotherapy
GemcitabineArm C: Nivolumab + Platinum doublet chemotherapy
PemetrexedArm C: Nivolumab + Platinum doublet chemotherapy
PaclitaxelArm C: Nivolumab + Platinum doublet chemotherapy

Purpose

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Trial Arms

NameTypeDescriptionInterventions
Arm A: NivolumabExperimentalNivolumab intravenously (IV) as specified
  • Nivolumab
Arm B: Nivolumab + IpilimumabExperimentalNivolumab + Ipilimumab IV as specified
  • Nivolumab
  • Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapyExperimentalNivolumab + Platinum doublet chemotherapy (IV) dose as specified
  • Nivolumab
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Pemetrexed
  • Paclitaxel
Arm D: Platinum doublet chemotherapyActive ComparatorChemotherapy administered on specified days of IV chemotherapy.
  • Carboplatin
  • Cisplatin
  • Gemcitabine
  • Pemetrexed
  • Paclitaxel

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or
             non-squamous histology, with no prior systemic anticancer therapy

          -  Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC)
             testing, with results, performed by the central lab during the Screening period

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

          -  Measurable disease by CT or MRI per response evaluation criteria in solid tumors
             version 1.1 (RECIST 1.1) criteria

        Exclusion Criteria:

          -  Subjects with untreated Central nervous system (CNS) metastases are excluded

          -  Subjects with an active, known or suspected autoimmune disease are excluded

          -  Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency
             virus (HIV) indicating acute or chronic infection

        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:Overall survival (OS)
Time Frame:approximately 48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Up to 48 months
Safety Issue:
Description:ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
Measure:Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
Time Frame:Up to 48 months
Safety Issue:
Description:Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment

Details

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

Last Updated

August 22, 2017