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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)

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ClinicalTrials.gov Identifier: NCT04026412
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 26, 2021
Actual Study Start Date  ICMJE August 20, 2019
Estimated Primary Completion Date October 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • 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 ]
  • Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C [ Time Frame: Up to 5 years ]
  • Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • 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 ]
  • Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  • 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 ]
  • Overall Survival (OS) for Arm A and Arm B [ Time Frame: Up to 55 months ]
  • Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • Progression-free survival (PFS) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 40 months ]
  • Objective response rate (ORR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • CR rate by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • DoR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • TTR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment [ Time Frame: Up to 7.5 years ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  • Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C [ Time Frame: Up to 40 months ]
  • Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  • Duration of Response (DOR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  • Time to Response (TTR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  • Time to Death or Distant Metastases (TTDM) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs [ Time Frame: Up to 2 years ]
  • Percentage of Participants Without Meaningful Symptom Deterioration Following 48 Weeks of Maintenance Therapy Based on Lung Cancer Subscale (LCS) of FACT-L and NSCLC-SAQ [ Time Frame: 48 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Biological: nivolumab
    Specified dose on specified days
  • Biological: ipilimumab
    Specified dose on specified days
  • Biological: durvalumab
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A: nivolumab + CCRT + ipilimumab
    Concurrent chemoradiotherapy (CCRT)
    Interventions:
    • Biological: nivolumab
    • Biological: ipilimumab
  • Experimental: Arm B: nivolumab + CCRT
    Concurrent chemoradiotherapy (CCRT)
    Intervention: Biological: nivolumab
  • Experimental: Arm C: CCRT + durvalumab
    Concurrent chemoradiotherapy (CCRT)
    Intervention: Biological: durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)		 1400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2024
Estimated Primary Completion Date October 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   France,   Germany,   Greece,   Ireland,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026412
Other Study ID Numbers  ICMJE CA209-73L
2019-001222-98 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP