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Trial record 10 of 80 for:    ACZ885

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: (None)

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ClinicalTrials.gov Identifier: NCT03447769
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Canakinumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : September 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: canakinumab
Participants will be administered receive canakinumab for 18 cycles (approximately 54 weeks).
Drug: Canakinumab
Canakinumab will be administered periodically for approximately 54 weeks.
Other Name: ACZ885

Placebo Comparator: Placebo
Participants will be administered receive canakinumab placebo for 18 cycles (approximately 54 weeks).
Drug: Placebo
Placebo will be administered periodically for approximately 54 weeks.




Primary Outcome Measures :
  1. Disease Free Survival (DFS) by local investigator [ Time Frame: up to 5 years ]
    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 :
  1. Overall Survival (OS) [ Time Frame: up to 5 years ]
    Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause.

  2. Lung Cancer Specific Survival (LCSS) [ Time Frame: up to 5 years ]
    To compare lung cancer specific survival in the canakinumab arm versus placebo arm

  3. Serum concentration-time profiles of canakinumab and appropriate individual PK parameters based on population PK model [ Time Frame: up to 5 years ]
    To characterize the pharmacokinetics of canakinumab therapy

  4. Serum concentrations of anti-canakinumab antibodies [ Time Frame: up to 5 years ]
    To characterize the prevalence and incidence of immunogenicity (anti-drug antibodies, ADA) of canakinumab

  5. Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire [ Time Frame: up to 5 years ]
    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

  6. 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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained prior to any screening procedures
  • Subjects 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
  • ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

  • Subjects with unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery
  • Subjects who 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, and completely resected carcinoma in situ of any type.
  • Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)
  • Subjects with a history of tuberculosis (TB) infection, active or latent, or one of the risk factors described in the protocol
  • Subjects with suspected or proven immunocompromised state as described in the protocol
  • Live vaccination within 3 months prior to first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447769


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

  Show 162 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03447769     History of Changes
Other Study ID Numbers: CACZ885T2301
2017-004011-39 ( EudraCT Number )
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data will be available according to the process described on www.clinicalstudydatarequest.com.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs