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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

NCT04026412

Description:

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)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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: 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)

Clinical Trial IDs

  • ORG STUDY ID: CA209-73L
  • SECONDARY ID: 2019-001222-98
  • NCT ID: NCT04026412

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
NivolumabArms A
IpilimumabArms A
DurvalumabArms C

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arms AExperimental
  • Nivolumab
  • Ipilimumab
Arms BExperimental
  • Nivolumab
Arms CExperimental
  • Durvalumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS) for Arm B and Arm C
Time Frame:Up to 55 months
Safety Issue:
Description:
Measure:Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C
Time Frame:Up to 40 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR
Time Frame:Up to 7.5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) Assessed as per BICR
Time Frame:Up to 7.5 years
Safety Issue:
Description:
Measure:Time to Response (TTR) Assessed as per BICR
Time Frame:Up to 7.5 years
Safety Issue:
Description:
Measure:Time to Death or Distant Metastases (TTDM) Assessed as per BICR
Time Frame:Up to 7.5 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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