A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in NSCLC Patients With EGFR Mutation Who Failed 1L or 2L EGFR TKI Therapy (CheckMate722)
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02864251 |
|
Recruitment Status :
Recruiting
First Posted : August 11, 2016
Last Update Posted : July 7, 2020
|
Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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) |
| Estimated Enrollment : | 580 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 : | October 20, 2016 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Nivolumab+Platinum doublet chemotherapy
Specified dose on specified days
|
Biological: Nivolumab
Other Names:
Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin |
|
Experimental: Nivolumab + Ipilimumab
Specified dose on specified days Enrollment is closed for this arm |
Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
|
|
Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
|
Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin |
Primary Outcome Measures :
- Progression free survival (PFS) in participants with epidermal growth factor receptor (EGFR) mutation positive non-small cell lung carcinoma (NSCLC) [ Time Frame: up to 47 months ]
Secondary Outcome Measures :
- Overall survival (OS) [ Time Frame: Up to 74 months ]
- Objective response rate (ORR) [ Time Frame: Up to 47 months ]
- Duration of response (DOR) [ Time Frame: Up to 47 months ]
- Progression free survival (PFS) rate [ Time Frame: Up to 47 months ]
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 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 subjects who were treated with osimertinib, T790M testing is not required.
- Subjects are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and subjects 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, subjects 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). Subjects with asymptomatic CNS metastasis are eligible.
- Eastern Cooperative Group (ECOG) Performance Status 0-1
- Life expectancy is at least 3 months
Exclusion Criteria:
- Subjects with known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These subjects are only eligible if they fail osimertinib as 2L.
- Subjects who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
- Subjects with carcinomatous meningitis
- Subjects with an active, known or suspected autoimmune disease are excluded
- Subjects with ALK translocation
- Subjects with 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 could 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
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
| Contact: First line of the email MUST contain NCT# and Site #. |
Locations
Show 122 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: | July 7, 2020 |
| Last Verified: | July 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Carboplatin Nivolumab Pemetrexed Ipilimumab Antineoplastic Agents Antineoplastic Agents, Immunological Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |