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)

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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

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

Trial contacts and locations

151

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Data sourced from clinicaltrials.gov

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