臨床研究等提出・公開システム

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)

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. (CANOPY-1)

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

completed

Dec. 21, 2018

Interventional

Multicenter, randomized, double-blind, placebo-controlled

treatment purpose

3

- 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

- 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.

Both

Non-small Cell Lung Cancer

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

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

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

Dec. 26, 2018