A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery (CheckMate73L)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Biological: durvalumab; Biological: nivolumab; Biological: ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04026412

CA209-73L

2019-001222-98 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 925 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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925 participants in 3 patient groups

Arm A: nivolumab + CCRT + ipilimumab

Experimental group

Description:

Concurrent chemoradiotherapy (CCRT)

Treatment:

Biological: ipilimumab

Biological: nivolumab

Arm B: nivolumab + CCRT

Experimental group

Description:

Concurrent chemoradiotherapy (CCRT)

Treatment:

Biological: nivolumab

Arm C: CCRT + durvalumab

Experimental group

Description:

Concurrent chemoradiotherapy (CCRT)

Treatment:

Biological: durvalumab