Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.
- Non-Small-Cell Lung
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
- Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
- Subject with ECOG performance status (PS) of 0 or 1.
- Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.
- Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
- Subject with EGFRor ALK positive tumor.
- History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.
Other protocol-defined inclusion/exclusion may apply.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Blinded Canakinumab administered at the recommended Phase III regimen (defined in the safety run-in part). Canakinumab will be given in combination with docetaxel (standard of care)||
|Matching placebo, administered at the recommended Phase III regimen (defined in the safety run-in part), in combination with docetaxel (standard of care)||
- Novartis Pharmaceuticals
Study ContactNovartis Pharmaceuticals