Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible. - 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 participant 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Ila Tamaskar, Site 0047
216-778-4568

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center http://www.bmsstudyconnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.