A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

NCT ID: NCT02864251

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 367 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2022-10-17

Brief Summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Conditions

Non-Small-Cell Lung Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nivolumab+Platinum doublet chemotherapy

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Pemetrexed

Intervention Type: DRUG

Specified dose on specified days

Cisplatin

Intervention Type: DRUG

Specified dose on specified days

Carboplatin

Intervention Type: DRUG

Specified dose on specified days

Nivolumab + Ipilimumab

Enrollment is closed for this arm

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type: BIOLOGICAL

Specified dose on specified days

Platinum doublet chemotherapy

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Specified dose on specified days

Cisplatin

Intervention Type: DRUG

Specified dose on specified days

Carboplatin

Intervention Type: DRUG

Specified dose on specified days

Interventions

Nivolumab

Specified dose on specified days

Intervention Type: BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type: BIOLOGICAL

Pemetrexed

Specified dose on specified days

Intervention Type: DRUG

Cisplatin

Specified dose on specified days

Intervention Type: DRUG

Carboplatin

Specified dose on specified days

Intervention Type: DRUG

Other Intervention Names

Opdivo; BMS-936558; Yervoy; BMS-734016

Eligibility Criteria

Inclusion Criteria

• Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib). In osimertinib treated subjects, T790 testing is not required.
• No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy. For participants who were treated with osimertinib, T790M testing is not required.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
• Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC).
• Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
• Eastern Cooperative Group (ECOG) Performance Status 0-1
• Life expectancy is at least 3 months

Exclusion Criteria

• Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
• who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
• Carcinomatous meningitis
• Active, known or suspected autoimmune disease are excluded
• ALK translocation
• Known SCLC transformation
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Pacific Shores Medical Group

Long Beach, California, United States

Local Institution - 0029

Los Angeles, California, United States

Local Institution - 0033

Los Angeles, California, United States

Local Institution - 0061

Orange, California, United States

Torrance Memorial Physican Network

Redondo Beach, California, United States

Local Institution - 0003

New Haven, Connecticut, United States

Local Institution - 0004

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Local Institution - 0002

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Local Institution - 0064

New York, New York, United States

Duke University Medical Center

Butner, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Texas Health Physicians Group

Arlington, Texas, United States

Baylor Scott and White Research Institute

Temple, Texas, United States

Local Institution - 0063

Tyler, Texas, United States

Local Institution - 0001

Salt Lake City, Utah, United States

Local Institution - 0166

Edmonton, Alberta, Canada

Local Institution - 0168

Montreal, Quebec, Canada

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Chongqing, Chongqing Municipality, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Zhengzhou, Henan, China

Local Institution

Hong Kong, HONG KONG, China

Local Institution - 0043

Changsha, Hunan, China

Local Institution

Changchun, Jilin, China

Local Institution

Changchun, Jilin, China

Local Institution

Xi'an, Shan3xi, China

Local Institution

Shanghai, Shanghai Municipality, China

Local Institution

Shanghai, Shanghai Municipality, China

Local Institution

Chengdu, Sichuan, China

Local Institution - 0016

Hangzhou, Zhejiang, China

Local Institution - 0017

Hangzhou, Zhejiang, China

Local Institution

Hangzhou, Zhejiang, China

Local Institution

Marseille, , France

Local Institution - 0156

Paris, , France

Local Institution

Rennes, , France

Local Institution

Toulouse, , France

Local Institution - 0027

Hong Kong, , Hong Kong

Local Institution - 0024

Hong Kong, , Hong Kong

Local Institution

Shatin, , Hong Kong

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Hirosaki-shi, Aomori, Japan

Local Institution

Matsuyama, Ehime, Japan

Local Institution

Iizuka, Fukuoka, Japan

Local Institution - 0059

Kurume, Fukuoka, Japan

Local Institution

Fukushima, Fukushima, Japan

Local Institution

Kōriyama, Fukushima, Japan

Local Institution

Fukuyama, Hiroshima, Japan

Local Institution

Hiroshima, Hiroshima, Japan

Local Institution - 0070

Sapporo, Hokkaido, Japan

Local Institution

Himeji-shi, Hyōgo, Japan

Local Institution - 0097

Itami, Hyōgo, Japan

Local Institution

Kobe, Hyōgo, Japan

Local Institution

Bunkyō City, Kanagawa, Japan

Local Institution - 0081

Yokohama, Kanagawa, Japan

Local Institution

Yokohama, Kanagawa, Japan

Local Institution

Yokohama, Kanagawa, Japan

Local Institution

Kumamoto, Kumamoto, Japan

Local Institution

Natori-shi, Miyagi, Japan

Local Institution - 0077

Sendai, Miyagi, Japan

Local Institution

Hirakata-shi, Osaka, Japan

Local Institution

Kishiwada Shi, Osaka, Japan

Local Institution

Sakai, Osaka, Japan

Local Institution - 0058

Sayama, Osaka, Japan

Local Institution - 0076

Hidaka, Saitama, Japan

Local Institution

Kitaadachi-gun, Saitama, Japan

Local Institution - 0069

Chūō, Tokyo, Japan

Local Institution - 0078

Koto-ku, Tokyo, Japan

Local Institution

Ube Shi, Yamaguchi, Japan

Local Institution

Chiba, , Japan

Local Institution

Fukuoka, , Japan

Local Institution

Fukuoka, , Japan

Local Institution

Niigata, , Japan

Local Institution - 0079

Tokyo, , Japan

Local Institution

Toyama, , Japan

Local Institution

Wakayama, , Japan

Local Institution - 0042

Singapore, , Singapore

Local Institution - 0041

Singapore, , Singapore

Local Institution - 0038

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0037

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0035

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution

Cheogju-si, , South Korea

Local Institution

Gyeonggi-do, , South Korea

Local Institution - 0036

Gyeonggi-do, , South Korea

Local Institution

Inchoen, , South Korea

Local Institution

Seoul, , South Korea

Local Institution - 0158

Barcelona, , Spain

Local Institution

L'Hospitalet de Llobregat, , Spain

Local Institution

Madrid, , Spain

Local Institution

Majadahonda, , Spain

Local Institution

Málaga, , Spain

Local Institution

Zaragoza, , Spain

Local Institution - 0021

Tainan City, TNN, Taiwan

Local Institution - 0045

Chiayi City, , Taiwan

Local Institution

Kaohsiung City, , Taiwan

Local Institution

Kaohsiung City, , Taiwan

Local Institution - 0019

Kaohsiung City, , Taiwan

Local Institution - 0018

Taichung, , Taiwan

Local Institution

Taichung, , Taiwan

Local Institution

Tainan City, , Taiwan

Local Institution

Taipei, , Taiwan

Local Institution - 0066

Taipei, , Taiwan

Local Institution - 0108

Taipei, , Taiwan

Local Institution - 0023

Taipei, , Taiwan

Local Institution

Taipei, , Taiwan

Local Institution

Taoyuan District, , Taiwan

Countries

United States; Canada; China; France; Hong Kong; Japan; Singapore; South Korea; Spain; Taiwan

References

Mok T, Nakagawa K, Park K, Ohe Y, Girard N, Kim HR, Wu YL, Gainor J, Lee SH, Chiu CH, Kim SW, Yang CT, Wu CL, Wu L, Lin MC, Samol J, Ichikado K, Wang M, Zhang X, Sylvester J, Li S, Forslund A, Yang JC. Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor-Mutated Metastatic Non-Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722. J Clin Oncol. 2024 Apr 10;42(11):1252-1264. doi: 10.1200/JCO.23.01017. Epub 2024 Jan 22.

Reference Type: DERIVED

PMID: 38252907 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

Other Identifiers

2017-002672-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-722

Identifier Type: -

Identifier Source: org_study_id