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Trial record 1 of 1 for:    NCT04026412
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A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery (CheckMate73L)

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: NCT04026412
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Biological: nivolumab Biological: ipilimumab Biological: durvalumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : October 17, 2022
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: nivolumab + CCRT + ipilimumab
Concurrent chemoradiotherapy (CCRT)
Biological: nivolumab
Specified dose on specified days

Biological: ipilimumab
Specified dose on specified days

Experimental: Arm B: nivolumab + CCRT
Concurrent chemoradiotherapy (CCRT)
Biological: nivolumab
Specified dose on specified days

Experimental: Arm C: CCRT + durvalumab
Concurrent chemoradiotherapy (CCRT)
Biological: durvalumab
Specified dose on specified days




Primary Outcome Measures :
  1. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C [ Time Frame: Up to 5 years ]
  2. Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C [ Time Frame: Up to 40 months ]
  2. Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  3. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B [ Time Frame: Up to 40 months ]
  4. Overall Survival (OS) for Arm A and Arm B [ Time Frame: Up to 55 months ]
  5. Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  6. Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  7. Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  8. Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  9. Progression-free survival (PFS) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 40 months ]
  10. Objective response rate (ORR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  11. CR rate by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  12. DoR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  13. TTR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  14. Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment [ Time Frame: Up to 7.5 years ]
  15. Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
  16. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  17. Proportion of participants without symptom deterioration based on LCS subscale of FACT-L and NSCLC-SAQ [ Time Frame: 48 Weeks ]
    Lung Cancer Subscale (LCS), Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ)



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.


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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:

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) histologically-confirmed NSCLC, according to 8th TNM classification
  • Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Exclusion Criteria:

  • Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the patient from adhering to the protocol or would increase the risk associated with study participation
  • Active infection requiring systemic therapy within 14 days prior to randomization
  • History of organ or tissue transplant that requires systemic use of immune suppressive agents
  • Prior thoracic radiotherapy

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): NCT04026412


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 #.

Locations
Show Show 177 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
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: NCT04026412    
Other Study ID Numbers: CA209-73L
2019-001222-98 ( EudraCT Number )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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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
Nivolumab
Ipilimumab
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents