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Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (CANOPY-2)

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ClinicalTrials.gov Identifier: NCT03626545
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 25, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE January 23, 2019
Estimated Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Safety run-in part: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 6 months ]
    Incidence of DLT assessed among a minimum of 6 evaluable subjects during 42 days of docetaxel and canakinumab treatment
  • Randomized part: Overall Survival (OS) [ Time Frame: 26 months from start of the randomization part ]
    Overall Survival (OS) is defined as the time from randomization to date of death due to any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Safety run-in part: Incidence of dose limiting toxicities (DLTs) [ Time Frame: 6 months ]
    Incidence of DLT assessed among a minimum of 6 evaluable subjects during 42 days of docetaxel and canakinumab treatment
  • Randomized part: Overall Survival (OS) [ Time Frame: 26 months from start of the randomization part ]
    Overall Survival (OS) is defined as the time from start of treatment to date of death due to any cause.
Change History Complete list of historical versions of study NCT03626545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Overall response rate (ORR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1
  • Duration of response (DOR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria
  • Disease control rate (DCR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Disease control rate is defined as the proportion of patients with CR or PR or subjects with SD as per local review according to RECIST 1.1 criteria
  • Randomized Part only: Progression-Free Survival (PFS) [ Time Frame: every 6 weeks during the first 12 months, then every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Progression-free survival is defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 response criteria or death due to any cause
  • Randomized part only: Time to Response (TTR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Time to response (TTR) is defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria
  • Randomized part only: Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms
  • Randomized part only: Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms
  • Randomized part only: change from baseline in score per the EORTC QLQ C30 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Randomized part only: change fropm baseline in score as per the EORTC-QLQ LC13 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Randomized part only: change from baseline in score as per the EQ-5D-5L questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Serum concentration-time profiles of canakinumab [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of canakinumab
  • Maximum serum concentration (Cmax) of canakimumab [ Time Frame: 26 months ]
    The Cmax values are based on the serum concentration-time profile of canakimuab. To characterize the pharmacokinetics of canakinumab
  • Steady-state trough concentrations (Ctrough) of canakinumab [ Time Frame: 26 months ]
    To caracterize the pharmacokinetics of canakinumab
  • Time of maximum serum concentration (Tmax) of canakinumab [ Time Frame: 26 months ]
    The Tmax values are based on the serum concentration-time profile of canakimuab. To characterize the pharmacokinetics of canakinumab.
  • Plasma concentration-time profiles of docetaxel [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of docetaxel
  • Maximum plasma concentration (Cmax) of docetaxel [ Time Frame: 26 months ]
    The Cmax values are based on the plasma concentration-time profile of docetaxel. To characterize the pharmacokinetics of docetaxel.
  • Antidrug antibodies (ADA) [ Time Frame: 26 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Overall response rate (ORR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1
  • Duration of response (DOR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria
  • Disease control rate (DCR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Disease control rate is defined as the proportion of patients with CR or PR or subjects with SD as per local review according to RECIST 1.1 criteria
  • Randomized Part only: Progression-Free Survival (PFS) [ Time Frame: every 6 weeks during the first 12 months, then every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression using RECIST 1.1 response criteria or death due to any cause
  • Randomized part only: Time to Response (TTR) [ Time Frame: every 6 weeks during the first 12 months and every 12 weeks thereafter until disease progression or death due to any cause, whichever occurs first (26 months) ]
    Time to response (TTR) is defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria
  • Randomized part only: Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms
  • Randomized part only: Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab vs placebo on time to onset or deterioration of lung cancer specific symptoms
  • Randomized part only: change from baseline in score per the EORTC QLQ C30 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Randomized part only: change fropm baseline in score as per the EORTC-QLQ LC13 questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Randomized part only: change from baseline in score as per the EQ-5D-5L questionnaire [ Time Frame: 26 months ]
    To assess the effect of canakinumab versus placebo on PROs (patient's health related quality of life)
  • Serum concentration-time profiles of canakinumab [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of canakinumab
  • Maximum serum concentration (Cmax) of canakimumab [ Time Frame: 26 months ]
    The Cmax values are based on the serum concentration-time profile of canakimuab. To characterize the pharmacokinetics of canakinumab
  • Steady-state trough concentrations (Ctrough) of canakinumab [ Time Frame: 26 months ]
    To caracterize the pharmacokinetics of canakinumab
  • Time of maximum serum concentration (Tmax) of canakinumab [ Time Frame: 26 months ]
    The Tmax values are based on the serum concentration-time profile of canakimuab. To characterize the pharmacokinetics of canakinumab.
  • Plasma concentration-time profiles of docetaxel [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of docetaxel
  • Maximum plasma concentration (Cmax) of docetaxel [ Time Frame: 26 months ]
    The Cmax values are based on the plasma concentration-time profile of docetaxel. To characterize the pharmacokinetics of docetaxel.
  • Antidrug antibodies (ADA) [ Time Frame: 26 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
Official Title  ICMJE 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)
Brief Summary This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Canakinumab
    Canakinumab, subcutaneous, administred at the recommended Phase III regimen (defined in the safety run-in part)
    Other Name: ACZ885
  • Drug: Docetaxel
    Standard of care: docetaxel 75mg/m2, intravenous, every 3 weeks
  • Other: Placebo
    Placebo, sub-cutaneous, administered at the recommended Phase III regimen (defined in the safety run-in part).
    Other Name: Placebo control
Study Arms  ICMJE
  • Experimental: Canakinumab
    Blinded Canakinumab administered at the recommended Phase III regimen (defined in the safety run-in part). Canakinumab will be given in combination with docetaxel (standard of care)
    Interventions:
    • Drug: Canakinumab
    • Drug: Docetaxel
  • Placebo Comparator: Placebo
    Matching placebo, administered at the recommended Phase III regimen (defined in the safety run-in part), in combination with docetaxel (standard of care)
    Interventions:
    • Drug: Docetaxel
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 10, 2021
Estimated Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
  • Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
  • Subject with ECOG performance status (PS) of 0 or 1.
  • Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.

Key Exclusion Criteria:

  • Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
  • Subject with EGFRor ALK positive tumor.
  • History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Other protocol-defined inclusion/exclusion may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   Czechia,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Jordan,   Korea, Republic of,   Lebanon,   Netherlands,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03626545
Other Study ID Numbers  ICMJE CACZ885V2301
2018-002480-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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 is currently available according to the process described on www.clinicalstudydatarequest.com.

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP