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Trial record 37 of 37 for:    Recruiting, Not yet recruiting, Available Studies | Receptor tyrosine kinase

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)

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ClinicalTrials.gov Identifier: NCT02864251
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Nivolumab+Platinum doublet chemotherapy
Specified dose on specified days
Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Experimental: Nivolumab + Ipilimumab

Specified dose on specified days

Enrollment is closed for this arm

Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin



Primary Outcome Measures :
  1. 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 :
  1. Overall survival (OS) [ Time Frame: Up to 74 months ]
  2. Objective response rate (ORR) [ Time Frame: Up to 47 months ]
  3. Duration of response (DOR) [ Time Frame: Up to 47 months ]
  4. Progression free survival (PFS) rate [ Time Frame: Up to 47 months ]


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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 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
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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 #.

  Show 112 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02864251     History of Changes
Other Study ID Numbers: CA209-722
2017-002672-38 ( EudraCT Number )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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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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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
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