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:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03215706

Trial Eligibility

Document

Title

  • Brief Title: A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
  • Official Title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

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
  • Ipilimumab
  • Nivolumab
  • 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:

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

          -  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

          -  Participants must have PD-L1 IHC testing with results performed by a central
             laboratory during the screening period

        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:From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.

Secondary Outcome Measures

Measure:Progression Free Survival (PFS) by BICR
Time Frame:From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Measure:Objective Response Rate (ORR) by BICR
Time Frame:From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.
Measure:Duration of Response (DoR)
Time Frame:From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
Measure:Time to Response (TTR)
Time Frame:From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.
Measure:Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
Time Frame:From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:PD-L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC 28-8 pharmDx test. PD-L1 expression was classified as PD-L1 ≥1% (≥1% tumor cells with membrane staining in a minimum of a hundred evaluable tumor cells), PD-L1 < 1% and PD-L1 not quantifiable (without quantifiable PD-L1 expression), PD-L1 expression ≥ 50%, PD-L1 expression 1 to 49%
Measure:PFS by BICR by PD-L1 Tumor Cell Expression
Time Frame:From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Measure:OS by PD-L1 Tumor Cell Expression
Time Frame:From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Safety Issue:
Description:OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

April 8, 2021