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 (CANOPY-1)

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: canakinumab; Drug: cisplatin; Drug: paclitaxel; Drug: pembrolizumab; Drug: carboplatin; Drug: pemetrexed; Drug: canakinumab matching placebo; Drug: nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03631199

2018-001547-32 (EudraCT Number)

CACZ885U2301

Details and patient eligibility

About

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.

Enrollment: 673 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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673 participants in 2 patient groups

canakinumab

Experimental group

Description:

canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy

Treatment:

Drug: nab-paclitaxel

Drug: pemetrexed

Drug: carboplatin

Drug: pembrolizumab

Drug: paclitaxel

Drug: cisplatin

Drug: canakinumab

canakinumab matching-placebo

Other group

Description:

canakinumab matching-placebo in combination with pembrolizumab and platinum-based doublet chemotherapy

Treatment:

Drug: nab-paclitaxel

Drug: canakinumab matching placebo

Drug: pemetrexed

Drug: carboplatin

Drug: pembrolizumab

Drug: paclitaxel

Drug: cisplatin