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

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Biological: durvalumab; Biological: nivolumab; Biological: ipilimumab

• Registration Number: NCT04026412
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2019-10-08
• Primary Completion: 2024-03-22
• Study Completion: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 925

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C: CCRT + durvalumab	durvalumab	Concurrent chemoradiotherapy (CCRT)
Arm A: nivolumab + CCRT + ipilimumab	nivolumab	Concurrent chemoradiotherapy (CCRT)
Arm A: nivolumab + CCRT + ipilimumab	ipilimumab	Concurrent chemoradiotherapy (CCRT)
Arm B: nivolumab + CCRT	nivolumab	Concurrent chemoradiotherapy (CCRT)

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C	Up to 7 years

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 7 years
PFS by RECIST 1.1 per BICR for Arm B vs Arm C	Up to 7 years
OS for Arm B vs Arm C	Up to 7 years
OS for Arm A vs Arm B	Up to 7 years
Time to Response (TTR) by RECIST 1.1 per BICR	Up to 7 years
PFS by RECIST 1.1 per BICR for Arm A vs Arm B	Up to 7 years
Objective Response Rate (ORR) by RECIST 1.1 per BICR	Up to 7 years
Duration of Response (DoR) by RECIST 1.1 per BICR	Up to 7 years
PFS by RECIST 1.1 per Investigator assessment	Up to 7 years
ORR by RECIST 1.1 per Investigator assessment	Up to 7 years
Incidence of select AEs	Up to 7 years
Incidence of Serious Adverse Events (SAEs)	Up to 7 years
DoR by RECIST 1.1 per Investigator assessment	Up to 7 years
TTR by RECIST 1.1 per Investigator assessment	Up to 7 years
Proportion of participants without symptom deterioration based on NSCLC-SAQ	Up to 7 years	Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ)
Time to Death or Distant Metastases (TTDM) by RECIST 1.1 per Investigator assessment	Up to 7 years
Overall Survival (OS) for Arm A vs Arm C	Up to 7 years

Trial Locations

Locations (179)

Local Institution - 0119; 🇺🇸 La Jolla, California, United States

Local Institution - 0207; 🇺🇸 San Francisco, California, United States

Local Institution - 0166; 🇺🇸 San Francisco, California, United States

Local Institution - 0129; 🇺🇸 Lone Tree, Colorado, United States

Local Institution - 0233; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0219; 🇺🇸 Orlando, Florida, United States

Local Institution - 0039; 🇺🇸 Pensacola, Florida, United States

Local Institution - 0125; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0165; 🇺🇸 Augusta, Georgia, United States

Local Institution - 0218; 🇺🇸 Edgewood, Kentucky, United States

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