Status: Active Trial | Marker: no marker

Title

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)

Study Number

NCT03631199

Indication

- Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC
- EGFR Wildtype
- ALK negative

Primary objective

The primary objectives of the study are to compare progression-free survival (PFS) by local investigator assessment as per RECIST1.1 and overall survival (OS) between the two study treatment arms.

In- and exclusion Criteria

Inclusion:
- Histologically confirmed locally advanced stage IIIB/IIIC (and is not eligible for
definitive chemo-radiation curative therapy) or stage IV (metastatic) NSCLC for treatment
in the first-line setting
• Subjects who received previous neo-adjuvant or adjuvant systemic therapy (other than
immunotherapies) will be eligible if neo-adjuvant or adjuvant therapy was completed
at least 12 months prior to the development of metastatic disease. Last dose of neoadjuvant or adjuvant therapy must be more than 12 months prior to enrollment/randomization
- Subject is a suitable candidate for platinum-doublet chemotherapy and pembrolizumab,
and does not have any contraindication(s) to these drugs as per locally approved label.

Exclusion:
• 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).
• Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (such as but
not limited to identified in exons 19, 20, or 21), and/or ALK rearrangement by locally
approved laboratory testing

Study design

Phase III, multicenter, randomized, two-arm study

Responsibilities

Sponsor Novartis Pharma GmbH
Tel. +49 911 2730
Fax: +49 911 27312683

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. J. Wolf

Last Update: 1. July 2019