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Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer (CheckMate 078)

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ClinicalTrials.gov Identifier: NCT02613507
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Nivolumab Drug: Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)
Actual Study Start Date : December 10, 2015
Actual Primary Completion Date : September 15, 2017
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
Drug: Nivolumab
Active Comparator: Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
Drug: Docetaxel



Primary Outcome Measures :
  1. Overall survival [ Time Frame: approximately 37 months after First Patient first visit ]
    Overall survival is defined as the time from randomization to the date of death


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: approximately 37 months after First Patient first visit ]
    ORR is defined as the number of subjects whose best overall response (BOR) of Complete response (CR) or partial response (PR) divided by the number of randomized subjects.

  2. Progression Free Survival (PFS), [ Time Frame: approximately 37 months after First Patient first visit ]
    PFS is defined as the time from randomization to the date of the first documented tumor progression as determined by investigators per RECIST 1.1, or death due to any cause

  3. Rate of Disease-related Symptom Improvement: [ Time Frame: approximately 37 months after First Patient first visit ]
    Proportion of subjects exhibiting disease related symptoms improvements as measured by Lung Cancer Symptom Scale (LCSS)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  • Disease progression experienced during or after one prior platinum containing doublet chemotherapy
  • Stage IIIb/IV or recurrent disease
  • Male and Female ≥ 18 years of age
  • Measurable disease per RECIST 1.1
  • Performance Status ≤ 1

Exclusion Criteria:

  • History of Carcinomatous meningitis
  • Active Central nervous system (CNS) metastases
  • History of auto immune diseases
  • Prior treatment with Docetaxel
  • Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or checkpoint pathways

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): NCT02613507


  Show 32 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02613507     History of Changes
Other Study ID Numbers: CA209-078
2015-001893-16 ( EudraCT Number )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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

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
Docetaxel
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs