A study of nivolumab and ipilimumab in untreated patients with stage 3 NSCLC that is unable or not planned to be removed by surgery
- Conditions
- Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001222-98-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1400
- 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
- Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
Other protocol defined inclusion criteria could apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 770
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630
- 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 treatment
- 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 exclusion criteria could apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To compare progression-free survival (PFS) for Arm A vs Arm C;Secondary Objective: - To compare OS for Arm A vs Arm C<br>-To evaluate PFS and OS for Arm B vs Arm C and Arm A vs Arm B<br>- To evaluate tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to BICR assessment<br>- To evaluate PFS and tumor response for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging<br>- To evaluate time to death or distant metastases (TTDM) for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B according to Investigator assessment of tumor imaging<br>- To assess safety and tolerability of study treatments<br>- To evaluate symptom deterioration for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs Arm B<br>;Primary end point(s): 1. Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR) ;Timepoint(s) of evaluation of this end point: 1. Up to 5 Years<br>
- Secondary Outcome Measures
Name Time Method