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

NCT02613507 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-0782015-001893-16
• Study Type: interventional
• Target: 504
• Locations: 4 countries
• Sites: 33

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Median Overall Survival

  OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive

  From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)

• Overall Survival Rate

  OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive. Rates provided are Kaplan-Meier estimates.

  From first dose to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  From date of first dose up to partial or complete response (up to approximately 90 months)

• Overall Survival (OS) in Subpopulations

  From randomization to the date of death or date participant was last known to be alive (up to approximately 90 months)

• Progression Free Survival (PFS)

  From the time of randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 90 months)

• Progression Free Survival Rate

  From the time of randomization up to 6 months

• Time to Treatment Failure (TTF)

  From randomization up to disease progression, death, or last dose (up to approximately 17 months)

Study Arms (2)

Arm A: Nivolumab

EXPERIMENTAL

Nivolumab Intravenous infusion specified dose on specified days

Drug: Nivolumab

Arm B: Docetaxel

ACTIVE COMPARATOR

Docetaxel Intravenous infusion specified dose on specified days

Drug: Docetaxel

Interventions

Nivolumab DRUG

Arm A: Nivolumab

Docetaxel DRUG

Arm B: Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (33)

Local Institution - 0051

Beijing, Beijing Municipality, 100021, China

Location

Local Institution - 0007

Beijing, Beijing Municipality, 100032, China

Location

Local Institution - 0032

Beijing, Beijing Municipality, 100071, China

Location

Local Institution - 0026

Beijing, Beijing Municipality, 100853, China

Location

Local Institution - 0020

Chongqing, Chongqing Municipality, 400042, China

Location

Local Institution - 0015

Fuzhou, Fujian, 350025, China

Location

Local Institution - 0003

Guangzhou, Guangdong, 510060, China

Location

Local Institution - 0002

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0024

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0023

Changsha, Hunan, 410008, China

Location

Local Institution - 0012

Changsha, Hunan, 410013, China

Location

Local Institution - 0034

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0006

Changchun, Jilin, 130012, China

Location

Local Institution - 0022

Changchun, Jilin, 130021, China

Location

Local Institution - 0017

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0025

Shanghai, Shanghai Municipality, 200433, China

Location

Local Institution - 0011

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0008

Hangzhou, Zhejiang, 0, China

Location

Local Institution - 0009

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0010

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0031

Beijing, 0, China

Location

Local Institution - 0029

Beijing, 100021, China

Location

Local Institution - 0014

Shanghai, 200030, China

Location

Local Institution - 0028

Shanghai, 200030, China

Location

Local Institution - 0049

Hong Kong, 0, Hong Kong

Location

Local Institution - 0039

Chelyabinsk, 454048, Russia

Location

Local Institution - 0052

Moscow, 105229, Russia

Location

Local Institution - 0046

Moscow, 121309, Russia

Location

Local Institution - 0042

Saint Petersburg, 194291, Russia

Location

Local Institution - 0040

Saint Petersburg, 197758, Russia

Location

Local Institution - 0041

Saint Petersburg, 198255, Russia

Location

Local Institution - 0048

Singapore, 119228, Singapore

Location

Local Institution - 0037

Singapore, 308433, Singapore

Location

Related Publications (2)

• Hu S, Tang Z, Harrison JP, Hertel N, Penrod JR, May JR, Juarez-Garcia A, Holdgate O. Economic Evaluation of Nivolumab Versus Docetaxel for the Treatment of Advanced Squamous and Non-squamous Non-small Cell Lung Cancer After Prior Chemotherapy in China. Pharmacoecon Open. 2023 Mar;7(2):273-284. doi: 10.1007/s41669-022-00383-x. Epub 2023 Mar 10.

  PMID: 36897427 DERIVED

• Wu YL, Lu S, Cheng Y, Zhou C, Wang J, Mok T, Zhang L, Tu HY, Wu L, Feng J, Zhang Y, Luft AV, Zhou J, Ma Z, Lu Y, Hu C, Shi Y, Baudelet C, Cai J, Chang J. Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial. J Thorac Oncol. 2019 May;14(5):867-875. doi: 10.1016/j.jtho.2019.01.006. Epub 2019 Jan 17.

  PMID: 30659987 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: November 24, 2015
• Study Start: December 11, 2015
• Primary Completion: September 15, 2017
• Study Completion: November 24, 2023
• Last Updated: November 19, 2024
• Results First Posted: February 22, 2019

Record last verified: 2024-11

Locations

SG (2); CN (24); RU (6); HK (1)