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

• Status: Active, not recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Docetaxel

Criteria

Key Inclusion Criteria:

• 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.

Key Exclusion 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.