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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 : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : December 7, 2018
Estimated Primary Completion Date : March 8, 2021
Estimated Study Completion Date : August 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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

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)
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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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)

  10. 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)

  11. Serum concentration-time profiles of canakinumab [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of canakinumab

  12. 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

  13. Steady-state trough concentrations (Ctrough) of canakinumab [ Time Frame: 26 months ]
    To caracterize the pharmacokinetics of canakinumab

  14. 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.

  15. Plasma concentration-time profiles of docetaxel [ Time Frame: 26 months ]
    To characterize the pharmacokinetics of docetaxel

  16. 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.

  17. Antidrug antibodies (ADA) [ Time Frame: 26 months ]


Information from the National Library of Medicine

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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

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.


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): NCT03626545


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

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03626545     History of Changes
Other Study ID Numbers: CACZ885V2301
2018-002480-26 ( EudraCT Number )
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 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 is currently 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 ):
CANOPY-2
ACZ885
canakinumab
docetaxel
NSCLC
Non Small Cell Lung Cancer
Carcinoma
IL-1β
PD-(L)1
CANOPY
second or third line therapy
PD-(L)1 inhibitors
platinum-based chemotherapy

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
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs