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 (CheckMate722)
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| ClinicalTrials.gov Identifier: NCT02864251 |
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Recruitment Status :
Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : April 5, 2021
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small-Cell Lung Carcinoma | Biological: Nivolumab Biological: Ipilimumab Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 365 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 17, 2017 |
| Estimated Primary Completion Date : | October 31, 2021 |
| Estimated Study Completion Date : | July 15, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Nivolumab+Platinum doublet chemotherapy |
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: Pemetrexed Specified dose on specified days Drug: Cisplatin Specified dose on specified days Drug: Carboplatin Specified dose on specified days |
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Experimental: Nivolumab + Ipilimumab
Enrollment is closed for this arm
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Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab Specified dose on specified days
Other Names:
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| Active Comparator: Platinum doublet chemotherapy |
Drug: Pemetrexed
Specified dose on specified days Drug: Cisplatin Specified dose on specified days Drug: Carboplatin Specified dose on specified days |
Primary Outcome Measures :
- Progression free survival (PFS) assessed by blinded independent central review (BICR) [ Time Frame: up to 47 months ]
Secondary Outcome Measures :
- Overall survival (OS) [ Time Frame: Up to 74 months ]
- Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST) 1.1 by BICR [ Time Frame: Up to 47 months ]
- Duration of response (DOR) by BICR [ Time Frame: Up to 47 months ]
- Progression free survival (PFS) rate by BICR [ Time Frame: Up to 47 months ]
Information from the National Library of Medicine
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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 Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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).
- No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy.
- 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). For participants who were treated with osimertinib, T790M testing is not required.
- 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
Other protocol defined inclusion/exclusion criteria apply
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): NCT02864251
Locations
Show 106 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02864251 |
| Other Study ID Numbers: |
CA209-722 2017-002672-38 ( EudraCT Number ) |
| First Posted: | August 11, 2016 Key Record Dates |
| Last Update Posted: | April 5, 2021 |
| Last Verified: | March 2021 |
| 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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Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Nivolumab Pemetrexed Ipilimumab Antineoplastic Agents Antineoplastic Agents, Immunological Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |