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: 21.1 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001222-98-ES
- 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
- Not specified
- 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) 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
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 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
- 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
- Secondary Outcome Measures
Name Time Method