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Trial record 1 of 1 for:    02574078
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A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02574078
Recruitment Status : Completed
First Posted : October 12, 2015
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 9, 2015
First Posted Date  ICMJE October 12, 2015
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE November 23, 2015
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • Group A: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
    Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first
  • Group A: Overall survival (OS) [ Time Frame: Up to approximately 60 months ]
    Overall survival (OS) is defined as the time from randomization to the date of death. A subject who has not died will be censored at last known date alive
  • Group B: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  • Group B: Overall survival (OS) [ Time Frame: Up to approximately 60 months ]
  • Group C: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  • Group C: Overall survival (OS) [ Time Frame: Up to approximately 60 months ]
  • Group D: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  • Group E: Number of Incidence of treatment-related Adverse events (AEs) leading to both study drugs discontinuation [ Time Frame: Up to approximately 60 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • Group A: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  • Group A: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  • Group B: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
    Duration of response (DOR) is defined as the time from first confirmed response (CR or PR) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first
  • Group B: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
    Objective response rate (ORR) is defined as the number and percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR)
  • Group C: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  • Group C: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  • Group D: Overall survival(OS) [ Time Frame: Up to approximately 48 months ]
  • Group D: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  • Group D: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  • Group E: PFS [ Time Frame: Up to approximately 48 months ]
  • Group E: ORR [ Time Frame: Up to approximately 48 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
Brief Summary The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
Detailed Description

Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)

**Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Nivolumab
    Other Name: Opdivo
  • Drug: Bevacizumab
  • Drug: Pemetrexed
  • Other: Best Supportive Care
    Palliative radiation, palliative surgery and/or other best supportive care treatments
  • Drug: nab-Paclitaxel
  • Drug: Paclitaxel
  • Drug: Docetaxel
  • Drug: Gemcitabine
  • Drug: Erlotinib
  • Drug: Crizotinib
  • Drug: Carboplatin
Study Arms  ICMJE
  • Experimental: Group A Nivolumab
    Opdivo specified dose on specified days
    Intervention: Drug: Nivolumab
  • Experimental: Group A Nivolumab + SOC maintenance therapy

    Opdivo/Bevacizumab specified dose on specified days

    Opdivo/Pemetrexed specified dose on specified days

    Interventions:
    • Drug: Nivolumab
    • Drug: Bevacizumab
    • Drug: Pemetrexed
  • Active Comparator: Group A SOC maintenance therapy

    Bevacizumab specified dose on specified days

    Pemetrexed specified dose on specified days

    Interventions:
    • Drug: Bevacizumab
    • Drug: Pemetrexed
  • Experimental: Group B Nivolumab
    Opdivo specified dose on specified days
    Intervention: Drug: Nivolumab
  • Group B Best supportive care
    Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
    Intervention: Other: Best Supportive Care
  • Active Comparator: Group C Investigator's choice chemotherapy

    Carboplatin/nab-paclitaxel specified dose on specified days

    Carboplatin/paclitaxel specified dose on specified days

    Carboplatin/pemetrexed specified dose on specified days

    Carboplatin/docetaxel specified dose on specified days

    Carboplatin/gemcitabine specified dose on specified days

    Paclitaxel specified dose on specified days

    Docetaxel specified dose on specified days

    Gemcitabine specified dose on specified days

    Pemetrexed specified dose on specified days

    Interventions:
    • Drug: Pemetrexed
    • Drug: nab-Paclitaxel
    • Drug: Paclitaxel
    • Drug: Docetaxel
    • Drug: Gemcitabine
    • Drug: Carboplatin
  • Experimental: Group C Nivolumb
    Opdivo specified dose on specified days
    Intervention: Drug: Nivolumab
  • Active Comparator: Group D Erlotinib
    Erlotinib specified dose on specified days
    Intervention: Drug: Erlotinib
  • Experimental: Group D Nivolumab + Erlotinib
    Opdivo/Erlotnib specified dose on specified days
    Interventions:
    • Drug: Nivolumab
    • Drug: Erlotinib
  • Experimental: Group E Nivolumab + Crizotinib
    Opdivo/Crizotinib specified dose on specified days
    Interventions:
    • Drug: Nivolumab
    • Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2021)		 341
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)		 1953
Actual Study Completion Date  ICMJE April 15, 2020
Actual Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Histologically confirmed locally advanced or stage IV NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
  • Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria:

  • Untreated or active/progressing Central Nervous system (CNS) metastases
  • Active, known or suspected autoimmune disease
  • Known history of testing positive for HIV or AIDS
  • Active or chronic infection of hepatitis B virus or hepatitis C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02574078
Other Study ID Numbers  ICMJE CA209-370
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP