Clinical Trials /

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

NCT03215706

Description:

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC)
  • Official Title: A Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: CA209-9LA
  • SECONDARY ID: 2017-001195-35
  • NCT ID: NCT03215706

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
IpilimumabYervoy, BMS734016Module A
NivolumabOpdivo, BMS936558Module A
CarboplatinModule A
PaclitaxelTaxolModule A
PemetrexedAlimtaModule A
CisplatinPlatinolModule A

Purpose

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Trial Arms

NameTypeDescriptionInterventions
Module AExperimentalChemotherapy/Biologics combined
  • Carboplatin
  • Paclitaxel
  • Pemetrexed
  • Cisplatin
Module BActive ComparatorChemotherapy Combination
  • Carboplatin
  • Paclitaxel
  • Pemetrexed
  • Cisplatin

Eligibility Criteria

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

        Inclusion Criteria:

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test [minimum sensitivity 25 units per litre (IU/L) or equivalent units of human
             chorionic gonadotropin (HCG)] within 24 hours prior to the start of study drug

          -  WOCBP must agree to follow instructions for methods(s) of contraception for the
             duration of treatment with nivolumab and 5 months after the last dose of nivolumab (ie
             30 days [duration of ovulatory cycle] plus the time required for nivolumab to undergo
             approximately five half-lives)

          -  Males who are sexually active with WOCBP must agree to follow instructions for
             method(s) of contraception for the duration of treatment with nivolumab and up to 7
             months after the last dose of nivolumab (ie 90 days [duration of sperm turnover] plus
             the time required for nivolumab to undergo approximately five half-lives)

        Exclusion Criteria:

          -  Participants with known epidermal growth factor receptor (EGFR) mutations which are
             sensitive to available targeted inhibitor therapy (including, but not limited to,
             deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded

          -  Participants with known anaplastic lymphoma kinase (ALK) translocations which are
             sensitive to available targeted inhibitor therapy are excluded

          -  Participants with untreated CNS metastases are excluded. Participants are eligible if
             CNS metastases are adequately treated and participants are neurologically returned to
             baseline (except for residual signs or symptoms related to the CNS treatment) for at
             least 2 weeks prior to first treatment

        Other protocol inclusion/exclusion criteria may 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:Up to 25 months
Safety Issue:
Description:To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to 25 months
Safety Issue:
Description:To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
Measure:Overall Response Rate (ORR)
Time Frame:Up to 25 months
Safety Issue:
Description:To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy
Measure:ORR
Time Frame:Up to 25 months
Safety Issue:
Description:In participants with different PD-L1 levels
Measure:PFS
Time Frame:Up to 25 months
Safety Issue:
Description:In participants with different PD-L1 levels
Measure:OS
Time Frame:Up to 25 months
Safety Issue:
Description:In participants with different PD-L1 levels
Measure:ORR
Time Frame:Up to 25 months
Safety Issue:
Description:In association with tumor cell total somatic mutation numbers
Measure:PFS
Time Frame:Up to 25 months
Safety Issue:
Description:In association with tumor cell total somatic mutation numbers
Measure:OS
Time Frame:Up to 25 months
Safety Issue:
Description:In association with tumor cell total somatic mutation numbers

Details

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

Last Updated

August 11, 2017