Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

• Status: Active, not recruiting
• Trial end date: 2022-09-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cisplatin; Paclitaxel; Pembrolizumab; Pemetrexed

Criteria

Key inclusion criteria:

• Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting

• Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.

• Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

• At least 1 measurable lesion by RECIST 1.1

Key exclusion criteria:

• Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).

• Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).

• Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.

• Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.

• Subject with suspected or proven immune-compromised state or infections.

• Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

Other protocol-defined inclusion/exclusion criteria may apply.