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 |
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Recruitment Status :
Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : May 1, 2018
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Nivolumab
Nivolumab Intravenous infusion specified dose on specified days
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Drug: Nivolumab |
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Active Comparator: Arm B: Docetaxel
Docetaxel Intravenous infusion specified dose on specified days
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Drug: Docetaxel |
Primary Outcome Measures :
- 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 :
- 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.
- 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
- 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, 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:
- 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |
Docetaxel Nivolumab Antibodies, Monoclonal Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |