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

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: 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

Study Description

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 Design


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

Drug Information available for: Docetaxel Nivolumab

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

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.


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

Contacts and Locations

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

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

BMS Clinical Trial Patient Recruiting This link exits the ClinicalTrials.gov site

Investigator Inquiry Form This link exits the ClinicalTrials.gov site


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

To Top