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Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

NCT03447769

Description:

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: CACZ885T2301
  • SECONDARY ID: 2017-004011-39
  • NCT ID: NCT03447769

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
CanakinumabACZ885canakinumab
PlaceboPlacebo

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
canakinumabExperimentalParticipants will be administered receive canakinumab for 18 cycles (approximately 54 weeks).
  • Canakinumab
PlaceboPlacebo ComparatorParticipants will be administered receive canakinumab placebo for 18 cycles (approximately 54 weeks).
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Have completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease
             only) OR have NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and are candidates for
             complete resection surgery

          -  Must have recovered from all toxicities related to prior systemic therapy to grade ≤ 1
             (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and
             grade 2 or less neuropathy are allowed to enter the study

          -  Have ECOG performance status (PS) of 0 or 1

        Exclusion Criteria:

          -  Have unresectable or metastatic disease, positive microscopic margins on the pathology
             report, and/or gross disease remaining at the time of surgery

          -  Have received neoadjuvant chemotherapy or neoadjuvant radiotherapy

          -  Presence or history of a malignant disease, other than the resected NSCLC, that has
             been diagnosed and/or required therapy within the past 3 years Exceptions to this
             exclusion include the following: completely resected basal cell and squamous cell skin
             cancers, completely resected carcinoma in situ of any type and hormonal maintenance
             for breast and prostate cancer > 3 years.

          -  Have a history of current diagnosis of cardiac disease

          -  Have uncontrolled diabetes

          -  Have known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C
             (positive or indeterminate central laboratory results)

          -  Subjects must be evaluated for tuberculosis as per local treatment guidelines or
             clinical practice. Subjects with active tuberculosis are not eligible.

          -  Have suspected or proven immunocompromised state as described in the protocol

          -  Had Live and attenuated vaccination within 3 months prior to first dose of study drug
             (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Free Survival (DFS) by local investigator
Time Frame:up to 5 years
Safety Issue:
Description:DFS will be assessed from the time from the date of randomization to the date of the first documented disease recurrence as assessed by local investigator radiologically or death due to any cause.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:up to 5 years
Safety Issue:
Description:Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause.
Measure:Lung Cancer Specific Survival (LCSS)
Time Frame:up to 5 years
Safety Issue:
Description:To compare lung cancer specific survival in the canakinumab arm versus placebo arm
Measure:Serum concentration-time profiles of canakinumab and appropriate individual PK parameters based on population PK model
Time Frame:up to 5 years
Safety Issue:
Description:To characterize the pharmacokinetics of canakinumab therapy
Measure:Serum concentrations of anti-canakinumab antibodies
Time Frame:up to 5 years
Safety Issue:
Description:To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab
Measure:Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire
Time Frame:up to 5 years
Safety Issue:
Description:To assess the effect of canakinumab versus placebo on PROs (EORTC QLQC30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health related quality of life
Measure:Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 together with
Time Frame:up to 5 years
Safety Issue:
Description:To assess the effect of canakinumab versus placebo on PROs (EORTC QLQC30 with QLQ-LC13 incorporated and EQ-5D) including functioning and health related quality of life

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
  • ACZ885
  • canakinumab
  • adjuvant
  • AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)

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