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.

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects - CANOPY-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224543

Enrollment

627

Registered

2019-02-01

Start date

2018-12-21

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : INN of investigational material : canakinumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

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. - Eastern Cooperative oncology group (ECOG) performance status of 0 or 1. - At least 1 measurable lesion by RECIST 1.1

Exclusion criteria

Exclusion criteria: - Previous immunotherapy or drugs of a similar mechanism of action (IL-1 beta inhibitor). - Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement by locally approved laboratory testing.

Design outcomes

Primary

Measure	Time frame
Safety run-in part: Incidence of DLTs assessed among at least 6 evaluable subjects during the first 42 days of study treatment Double-blind, randomized, placebo-controlled part: Progression free survival is defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1	—

Countries

Asia except Japan, Japan

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: May 29, 2026