An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02041533
First received: January 19, 2014
Last updated: August 23, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

Condition Intervention Phase
Stage IV or Recurrent Non-Small Cell Lung Cancer
Biological: Nivolumab
Drug: Gemcitabine
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of the first documented tumor progression as determined by the IRRC (per RECIST 1.1), or death due to any cause


Secondary Outcome Measures:
  • Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]
    ORR is defined as the number of subjects whose best confirmed objective response is a complete response (CR) or partial response (PR), divided by the number of randomized subjects among strongly PD-L1+ subjects

  • Overall survival (OS) in subjects with strongly PD-L1+ tumor expression [ Time Frame: At least 33 months ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization to the date of death

  • PFS in all subjects with any PD-L1+ tumor expression [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]
  • Disease related symptom improvement in all subjects [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]
    Disease-related symptom improvement rate is defined as the proportion of randomized subjects who had a disease-related symptom improvement as measured by the lung cancer symptom scale (LCSS) among all PD-L1+ subjects


Estimated Enrollment: 535
Study Start Date: March 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab subjects
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Active Comparator: Arm B: Investigator's Choice Chemotherapy

Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first

Squamous subjects:

  • Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or
  • Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or
  • Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle

Non-Squamous subjects:

  • Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle
  • Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle

Optional crossover:

  • Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Drug: Gemcitabine
Other Name: Gemzar
Drug: Cisplatin
Other Name: Platinol
Drug: Carboplatin
Other Name: Paraplatin
Drug: Paclitaxel
Other Name: Taxol
Drug: Pemetrexed
Other Name: Alimta

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
  • Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
  • PD-L1+ on immunohistochemistry testing performed by central lab
  • Men and women, ages ≥ 18 years of age

Exclusion Criteria:

  • Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
  • Known anaplastic lymphoma kinase (ALK) translocations
  • Untreated central nervous system (CNS) metastases
  • Previous malignancies
  • Active, known or suspected autoimmune disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041533

  Show 140 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02041533     History of Changes
Other Study ID Numbers: CA209-026  2012-004502-93 
Study First Received: January 19, 2014
Last Updated: August 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Japan: Foundation for Biomedical Research and Innovation
Japan: Institutional Review Board
Japan: Ministry of Education, Culture, Sports, Science and Technology
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Korea: Institutional Review Board
Korea: Ministry for Health and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Romania: National Medicines Agency
Switzerland: Federal Office of Public Health
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Taiwan: Center for Drug Evaluation
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
Turkey: Ministry of Health
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Science and Higher Education
Taiwan: Department of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Switzerland: Swissmedic

Additional relevant MeSH terms:
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
Paclitaxel
Gemcitabine
Nivolumab
Cisplatin
Carboplatin
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 23, 2016