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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)

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ClinicalTrials.gov Identifier: NCT04026412
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Nivolumab Drug: Ipilimumab Drug: 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)
Estimated Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 11, 2023
Estimated Study Completion Date : April 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arms A Drug: Nivolumab
Specified dose on specified days

Drug: Ipilimumab
Q6W in maintenance period in Arm A

Experimental: Arms B Drug: Nivolumab
Specified dose on specified days

Experimental: Arms C Drug: Durvalumab
Q2W in maintenance in Arm C




Primary Outcome Measures :
  1. 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 ]
  2. Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  2. Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C [ Time Frame: Up to 40 months ]
  3. Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  4. Duration of Response (DOR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  5. Time to Response (TTR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  6. Time to Death or Distant Metastases (TTDM) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  7. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs [ Time Frame: Up to 2 years ]
  8. 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 ]


Information from the National Library of Medicine

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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

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


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 #.

  Show 52 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     History of Changes
Other Study ID Numbers: CA209-73L
2019-001222-98 ( EudraCT Number )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 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
Nivolumab
Ipilimumab
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents