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Lung Cancer (CANOPY-1)

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).

Overview

This Study Is Recruiting: Phase III Actual Start Date: [December 21, 2018] Estimated Completion Date: [May 31, 2021] Novartis Reference Number: CACZ885U2301
Condition: Lung Cancer Interventions: Canakinumab, pembrolizumab, platinum-based doublet chemotherapy, placebo Estimated Enrollment: [627 participants] ClinicalTrials.gov Identifier: NCT03631199
This Study Is Recruiting: Phase III Actual Start Date: [December 21, 2018]
Estimated Completion Date: [May 31, 2021] Novartis Reference Number: CACZ885U2301
Condition: Lung Cancer Interventions: Canakinumab, pembrolizumab, platinum-based doublet chemotherapy, placebo
Estimated Enrollment: [627 participants] ClinicalTrials.gov Identifier: NCT03631199

Study Goal

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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Eligibility

Participants may be eligible to participate if they:

  • Are 18 years or older
  • Have histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
  • Have not received previous immunotherapy or prior treatment with canakinumab or drugs of a similar mechanism of action (i.e. IL-1β inhibitor)
  • Meet other eligibility criteria

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

Other lung cancer trials you might be interested in:

A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC) (CANOPY A)

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

Definitions:
CANOPY - CANakinumab Outcomes in Patients with NSCLC StudY, ICF - informed consent form, NSCLC - non-small cell lung cancer

Last Updated: August 2, 2019

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