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A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

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ClinicalTrials.gov Identifier: NCT03215706
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: Ipilimumab Biological: Nivolumab Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : February 25, 2020
Estimated Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Module A
Chemotherapy/Biologics combined
Biological: Ipilimumab
Specified dose on specified day
Other Name: Yervoy, BMS734016

Biological: Nivolumab
Specified dose on specified day
Other Name: Opdivo, BMS936558

Drug: Carboplatin
Specified dose on specified day

Drug: Paclitaxel
Specified dose on specified day
Other Name: Taxol

Drug: Pemetrexed
Specified dose on specified day
Other Name: Alimta

Drug: Cisplatin
Specified dose on specified day
Other Name: Platinol

Active Comparator: Module B
Chemotherapy Combination
Drug: Carboplatin
Specified dose on specified day

Drug: Paclitaxel
Specified dose on specified day
Other Name: Taxol

Drug: Pemetrexed
Specified dose on specified day
Other Name: Alimta

Drug: Cisplatin
Specified dose on specified day
Other Name: Platinol




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 31 months ]
    To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 31 months ]
    To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy

  2. Overall Response Rate (ORR) [ Time Frame: Up to 31 months ]
    To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy

  3. ORR [ Time Frame: Up to 31 months ]
    In participants with different PD-L1 levels

  4. PFS [ Time Frame: Up to 31 months ]
    In participants with different PD-L1 levels

  5. OS [ Time Frame: Up to 31 months ]
    In participants with different PD-L1 levels

  6. ORR, PFS, OS: In association with tumor mutation numbers [ Time Frame: Up to 31 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215706


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 131 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03215706     History of Changes
Other Study ID Numbers: CA209-9LA
2017-001195-35 ( EudraCT Number )
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Nivolumab
Pemetrexed
Ipilimumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors