Lung Cancer (CANOPY-A)

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Lung Cancer (CANOPY-A)

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).

Overview

This study is recruiting: Phase III Actual Start Date: [March 16, 2018] Estimated Completion Date: [September 15, 2025] Novartis Reference Number: CACZ885T2301
Condition: Lung Cancer Interventions: canakinumab, placebo Estimated Enrollment: [1500 participants] ClinicalTrials.gov Identifier: NCT03447769
This study is recruiting: Phase III Actual Start Date: [March 16, 2018]
Estimated Completion Date: [September 15, 2025] Novartis Reference Number: CACZ885T2301
Condition: Lung Cancer Interventions: canakinumab, placebo
Estimated Enrollment: [1500 participants] ClinicalTrials.gov Identifier: NCT03447769

Study Goal

The primary purpose of the study is to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II -IIIA and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

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 been diagnosed with early (Stage IIA-IIIB) NSCLC
  • Have undergone surgery for lung cancer with complete resection (R0)
  • Have completed standard-of-care chemotherapy and/or radiation therapy
  • 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.

Definitions:
Non-small Cell Lung Cancer (NSCLC)

Last Updated: May 1, 2019

4/19 M-GON-1210821