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A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370)

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ClinicalTrials.gov Identifier: NCT02574078
Recruitment Status : Active, not recruiting
First Posted : October 12, 2015
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Bevacizumab Drug: Pemetrexed Other: Best Supportive Care Drug: nab-Paclitaxel Drug: Paclitaxel Drug: Docetaxel Drug: Gemcitabine Drug: Erlotinib Drug: Crizotinib Drug: Carboplatin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 13, 2015
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A Nivolumab
Opdivo specified dose on specified days
 Drug: Nivolumab
Other Name: Opdivo
Experimental: Group A Nivolumab + SOC maintenance therapy

Opdivo/Bevacizumab specified dose on specified days

Opdivo/Pemetrexed specified dose on specified days

 Drug: Nivolumab
Other Name: Opdivo

Drug: Bevacizumab
Drug: Pemetrexed
Active Comparator: Group A SOC maintenance therapy

Bevacizumab specified dose on specified days

Pemetrexed specified dose on specified days

 Drug: Bevacizumab
Drug: Pemetrexed
Experimental: Group B Nivolumab
Opdivo specified dose on specified days
 Drug: Nivolumab
Other Name: Opdivo
Group B Best supportive care
Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery
 Other: Best Supportive Care
Palliative radiation, palliative surgery and/or other best supportive care treatments
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

 Drug: Pemetrexed
Drug: nab-Paclitaxel
Drug: Paclitaxel
Drug: Docetaxel
Drug: Gemcitabine
Drug: Carboplatin
Experimental: Group C Nivolumb
Opdivo specified dose on specified days
 Drug: Nivolumab
Other Name: Opdivo
Active Comparator: Group D Erlotinib
Erlotinib specified dose on specified days
 Drug: Erlotinib
Experimental: Group D Nivolumab + Erlotinib
Opdivo/Erlotnib specified dose on specified days
 Drug: Nivolumab
Other Name: Opdivo

Drug: Erlotinib
Experimental: Group E Nivolumab + Crizotinib
Opdivo/Crizotinib specified dose on specified days
 Drug: Nivolumab
Other Name: Opdivo

Drug: Crizotinib


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Group B: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  4. Group B: Overall survival (OS) [ Time Frame: Up to approximately 60 months ]
  5. Group C: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  6. Group C: Overall survival (OS) [ Time Frame: Up to approximately 60 months ]
  7. Group D: Progression-free survival (PFS) [ Time Frame: Up to approximately 48 months ]
  8. Group E: Number of Incidence of treatment-related Adverse events (AEs) leading to both study drugs discontinuation [ Time Frame: Up to approximately 60 months ]

Secondary Outcome Measures :
  1. Group A: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  2. Group A: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  3. 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

  4. 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)

  5. Group C: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  6. Group C: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  7. Group D: Overall survival(OS) [ Time Frame: Up to approximately 48 months ]
  8. Group D: Duration of response (DOR) [ Time Frame: Up to approximately 48 months ]
  9. Group D: Objective Response rate (ORR) [ Time Frame: Up to approximately 48 months ]
  10. Group E: PFS [ Time Frame: Up to approximately 48 months ]
  11. Group E: ORR [ Time Frame: Up to approximately 48 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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 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
Contacts and Locations
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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): NCT02574078


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02574078    
Other Study ID Numbers: CA209-370
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
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
Gemcitabine
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Bevacizumab
 Carboplatin
Nivolumab
Pemetrexed
Crizotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs