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Non-Small-Cell Lung CarcinomaPhase 3CheckMate722NCT02864251

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

A Phase 3 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 109 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
Nivolumab, Ipilimumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
109 sitesin 10 countries
Study dates
17 Mar 2017to 17 Oct 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

109 sites in 10 countries.

109 sites in 10 countries

Japan36 sites

  • Local Institution

    Bunkyō City, Kanagawa, 1138603

  • Local Institution

    Chiba, 2608670

  • Local Institution - 0069

    Chūō, Tokyo, 104-0045

  • Local Institution

    Fukuoka, 810-0001

  • Local Institution

    Fukuoka, 812-8582

  • Local Institution

    Fukushima, Fukushima, 9601295

  • Local Institution

    Fukuyama, Hiroshima, 7210971

  • Local Institution - 0076

    Hidaka, Saitama, 350-1298

  • Local Institution

    Himeji-shi, Hyōgo, 6708520

  • Local Institution

    Hirakata-shi, Osaka, 573-1191

  • Local Institution

    Hirosaki-shi, Aomori, 036-8174

  • Local Institution

    Hiroshima, Hiroshima, 7348551

  • Local Institution

    Iizuka, Fukuoka, 8208505

  • Local Institution - 0097

    Itami, Hyōgo, 6648540

  • Local Institution

    Kishiwada Shi, Osaka, 5968501

  • Local Institution

    Kitaadachi-gun, Saitama, 362-0806

  • Local Institution

    Kobe, Hyōgo, 6500047

  • Local Institution

    Kōriyama, Fukushima, 9630197

  • Local Institution - 0078

    Koto-ku, Tokyo, 1358550

  • Local Institution

    Kumamoto, Kumamoto, 861-4193

  • Local Institution - 0059

    Kurume, Fukuoka, 830-0011

  • Local Institution

    Matsuyama, Ehime, 791-0280

  • Local Institution

    Nagoya, Aichi-ken, 4648681

  • Local Institution

    Natori-shi, Miyagi, 981-1293

  • Local Institution

    Niigata, 990-9585

  • Local Institution

    Sakai, Osaka, 591-8555

  • Local Institution - 0070

    Sapporo, Hokkaido, 003-0804

  • Local Institution - 0058

    Sayama, Osaka, 589-8511

  • Local Institution - 0077

    Sendai, Miyagi, 9800873

  • Local Institution - 0079

    Tokyo, 1600023

  • Local Institution

    Toyama, 930-8550

  • Local Institution

    Ube Shi, Yamaguchi, 7550241

  • Local Institution

    Wakayama, 6418510

  • Local Institution - 0081

    Yokohama, Kanagawa, 2210855

  • Local Institution

    Yokohama, Kanagawa, 236-0051

  • Local Institution

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

United States18 sites

  • Texas Health Physicians Group

    Arlington, Texas, 76012

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Local Institution - 0002

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Duke University Medical Center

    Butner, North Carolina, 27509-1626

  • Local Institution - 0004

    Chicago, Illinois, 60637

  • Pacific Shores Medical Group

    Long Beach, California, 90808

  • Local Institution - 0029

    Los Angeles, California, 90017

  • Local Institution - 0033

    Los Angeles, California, 90095

  • Local Institution - 0003

    New Haven, Connecticut, 06520

  • Local Institution - 0064

    New York, New York, 10016

  • Local Institution - 0061

    Orange, California, 92868

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Torrance Memorial Physican Network

    Redondo Beach, California, 90277

  • Local Institution - 0001

    Salt Lake City, Utah, 84112

  • Baylor Scott and White Research Institute

    Temple, Texas, 76508

  • Local Institution - 0063

    Tyler, Texas, 75701

Other trials in United States

China16 sites

  • Local Institution

    Beijing, Beijing Municipality, 100730

  • Local Institution

    Beijing, Beijing Municipality, 100853

  • Local Institution

    Changchun, Jilin, 130012

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution - 0043

    Changsha, Hunan, 410013

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Chongqing, Chongqing Municipality, 400042

  • Local Institution

    Guangzhou, Guangdong, 510000

  • Local Institution - 0016

    Hangzhou, Zhejiang, 310006

  • Local Institution - 0017

    Hangzhou, Zhejiang, 310011

  • Local Institution

    Hangzhou, Zhejiang, 310016

  • Local Institution

    Hong Kong, HONG KONG

  • Local Institution

    Shanghai, Shanghai Municipality, 200025

  • Local Institution

    Shanghai, Shanghai Municipality, 200030

  • Local Institution

    Xi'an, Shan3xi, 710032

  • Local Institution

    Zhengzhou, Henan, 450008

Other trials in China

Taiwan14 sites

  • Local Institution - 0045

    Chiayi City, 62247

  • Local Institution

    Kaohsiung City, 807

  • Local Institution

    Kaohsiung City, 82445

  • Local Institution - 0019

    Kaohsiung City, 83301

  • Local Institution - 0018

    Taichung, 40447

  • Local Institution

    Taichung, 40705

  • Local Institution - 0021

    Tainan, TNN, 704

  • Local Institution

    Tainan, 736

  • Local Institution

    Taipei, 10002

  • Local Institution - 0066

    Taipei, 10449

  • Local Institution - 0108

    Taipei, 11031

  • Local Institution - 0023

    Taipei, 112

  • Local Institution

    Taipei, 114

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

South Korea8 sites

  • Local Institution

    Cheogju-si, 361-711

  • Local Institution

    Gyeonggi-do, 10408

  • Local Institution - 0036

    Gyeonggi-do, 463-707

  • Local Institution

    Inchoen, 405-760

  • Local Institution - 0038

    Seoul, Seoul Teugbyeolsi, 03722

  • Local Institution - 0037

    Seoul, Seoul Teugbyeolsi, 05505

  • Local Institution - 0035

    Seoul, Seoul Teugbyeolsi, 06351

  • Local Institution

    Seoul, 06591

Other trials in South Korea

Spain6 sites

  • Local Institution - 0158

    Barcelona, 08035

  • Local Institution

    L'Hospitalet de Llobregat, 08907

  • Local Institution

    Madrid, 28041

  • Local Institution

    Majadahonda, 28222

  • Local Institution

    Málaga, 29010

  • Local Institution

    Zaragoza, 50009

Other trials in Spain

France4 sites

  • Local Institution

    Marseille, 13915

  • Local Institution - 0156

    Paris, 75005

  • Local Institution

    Rennes, 35033

  • Local Institution

    Toulouse, 31059

Other trials in France

Hong Kong3 sites

  • Local Institution - 0027

    Hong Kong, 0

  • Local Institution - 0024

    Hong Kong

  • Local Institution

    Shatin

Other trials in Hong Kong

Canada2 sites

  • Local Institution - 0166

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0168

    Montreal, Quebec, H4A3J1

Other trials in Canada

Singapore2 sites

  • Local Institution - 0042

    Singapore, 119074

  • Local Institution - 0041

    Singapore, 308433

Other trials in Singapore

About this study

Official title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called Opdivo, BMS-936558

    Specified dose on specified days

  • IpilimumabBiological

    Also called Yervoy, BMS-734016

    Specified dose on specified days

  • PemetrexedDrug

    Specified dose on specified days

  • CisplatinDrug

    Specified dose on specified days

  • CarboplatinDrug

    Specified dose on specified days

Study groups in NCT02864251
Study groupRoleWhat they receive
Nivolumab+Platinum doublet chemotherapyExperimentalNot described
Receives: Biological: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Nivolumab + IpilimumabExperimentalEnrollment is closed for this arm
Receives: Biological: Nivolumab; Biological: Ipilimumab
Platinum doublet chemotherapyActive comparatorNot described
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)

    PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.

    Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy.

    Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment.

    Based on Kaplan-Meier estimates

    Measured: From randomization to the date of first documented tumor progression or death (approximately 58 months)

Secondary outcomes (5)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.

    Median based on Kaplan-Meier Estimates

    Measured: From randomization to the date of death due to any cause (up to approximately 67 months)

  2. Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)

    ORR is number of randomized participants who have confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using RECIST v1.1 criteria by BICR assessment.

    BOR is the best response designation, between randomization and objectively documented progression per RECIST v1.1 criteria by BICR or the date of subsequent anti-cancer therapy, whichever occurs first.

    PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to <10 mm (whether target or non-target).

    Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.

    CR+PR, confidence interval based on the Clopper and Pearson method.

    Measured: From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)

  3. Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)

    DOR is the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not included), whichever occurred first.

    PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in the short axis of pathological lymph nodes to <10 mm (whether target or non-target).

    Radiographic tumor response assessments from Week 7 (± 7 days), then every 6 weeks (± 7 days) until Week 49 and every 12 weeks (± 7 days) thereafter, until disease progression, treatment discontinued, or the start of subsequent anti-cancer therapy.

    Participants who neither progress nor die were censored on the date of their last assessment.

    Median computed using Kaplan-Meier method

    Measured: From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)

  4. 9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

    The PFSR at 9 months is defined as the percent of treated participants remaining progression free and surviving at 9 months since the first dosing date. Progression is the appearance of one or more new lesions.

    Point estimates are derived from Kaplan-Meier analyses.

    Measured: 9 months after first treatment dose

  5. 12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)

    The PFSR at 12 months is defined as the percent of treated participants remaining progression free and surviving at 12 months since the first dosing date. Progression is the appearance of one or more new lesions. Point estimates are derived from Kaplan-Meier analyses.

    Measured: 12 Months after first treatment dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2016 (estimated)
  2. Study start17 Mar 2017
  3. Primary completion20 Jan 2022
  4. Study completion17 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864251
Sponsor's protocol ID
CA209-722
Other IDs
2017-002672-38, 2017
Acronym
CheckMate722
Status last verified
Sep 2023
First submitted
9 Aug 2016
Last updated
28 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38252907

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Pemetrexed in people with Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb at 109 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Japan, United States, China, Taiwan, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR) (time frame: From randomization to the date of first documented tumor progression or death (approximately 58 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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