Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    checkmate 73L | NSCLC
Previous Study | Return to List | Next Study

A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 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 : December 12, 2019
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 December 12, 2019
Actual Study Start Date  ICMJE August 20, 2019
Estimated Primary Completion Date October 11, 2023   (Final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04026412 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
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 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 + CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer
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
  • Drug: Nivolumab
    Specified dose on specified days
  • Drug: Ipilimumab
    Q6W in maintenance period in Arm A
  • Drug: Durvalumab
    Q2W in maintenance in Arm C
Study Arms  ICMJE
  • Experimental: Arms A
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Arms B
    Intervention: Drug: Nivolumab
  • Experimental: Arms C
    Intervention: Drug: 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 April 12, 2024
Estimated Primary Completion Date October 11, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Active infection requiring systemic therapy within 14 days prior to randomization.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured,
  • Participants with an active, known or suspected autoimmune disease or a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of randomization.
  • History of organ or tissue transplant that requires systemic use of immune suppressive agents.
  • Clinical evidence of hearing loss and prior thoracic radiotherapy.

Other protocol defined inclusion/exclusion criteria could 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,   France,   Germany,   Greece,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Spain,   Sweden,   Switzerland,   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 December 2019

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