Clincosm LogoSign in Get a demo

CANOPY-2: 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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03626545
Collaborator
(none)
245
Enrollment
78
Locations
2
Arms
34.9
Actual Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
245 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)
Actual Study Start Date :
Jan 23, 2019
Actual Primary Completion Date :
Jan 8, 2021
Actual Study Completion Date :
Dec 20, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • Placebo control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety run-in part: Incidence of dose limiting toxicities (DLTs) [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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 [26 months]

      To characterize the pharmacokinetics of canakinumab

    12. Maximum serum concentration (Cmax) of canakimumab [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 [26 months]

      To caracterize the pharmacokinetics of canakinumab

    14. Time of maximum serum concentration (Tmax) of canakinumab [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 [26 months]

      To characterize the pharmacokinetics of docetaxel

    16. Maximum plasma concentration (Cmax) of docetaxel [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) [26 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University School of Medicine/Winship Cancer Institute Atlanta Georgia United States 30322
    2 Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory Kansas City Missouri United States 64111
    3 Montefiore Medical Center Albert Einstein College of Med Bronx New York United States 10461
    4 University of Cincinnati Cancer Institute Cincinnati Ohio United States 45267
    5 MD Anderson Houston Texas United States 77030
    6 Huntsman Cancer Institute Univ of Utah Salt Lake City Utah United States 84112 0550
    7 Novartis Investigative Site Berazategui Buenos Aires Argentina B1884BBF
    8 Novartis Investigative Site Caba Buenos Aires Argentina C1426ANZ
    9 Novartis Investigative Site Mar del Plata Buenos Aires Argentina B7600FZN
    10 Novartis Investigative Site La Rioja Argentina 5300
    11 Novartis Investigative Site Santiago del Estero Argentina 4200
    12 Novartis Investigative Site Greenslopes Queensland Australia 4120
    13 Novartis Investigative Site Shepparton Victoria Australia 3630
    14 Novartis Investigative Site Sint Niklaas Vlaams Brabant Belgium 9100
    15 Novartis Investigative Site Bruxelles Belgium 1200
    16 Novartis Investigative Site Charleroi Belgium 6000
    17 Novartis Investigative Site Gent Belgium 9000
    18 Novartis Investigative Site Roeselare Belgium 8800
    19 Novartis Investigative Site Salvador BA Brazil 40170-110
    20 Novartis Investigative Site Porto Alegre RS Brazil 90880-480
    21 Novartis Investigative Site Itajai SC Brazil 88301-229
    22 Novartis Investigative Site Vancouver British Columbia Canada V5Z 4E6
    23 Novartis Investigative Site Montreal Quebec Canada H4A 3J1
    24 Novartis Investigative Site Santiago Chile
    25 Novartis Investigative Site Chengdu Sichuan China 610041
    26 Novartis Investigative Site Shanghai China 200433
    27 Novartis Investigative Site Brno - Bohunice Czechia 639 01
    28 Novartis Investigative Site Ostrava Vitkovice Czechia 703 84
    29 Novartis Investigative Site Herlev Denmark DK 2730
    30 Novartis Investigative Site Odense C Denmark DK 5000
    31 Novartis Investigative Site Le Mans Cedex 09 France 72037
    32 Novartis Investigative Site Besancon Cedex France 25030
    33 Novartis Investigative Site Bordeaux Cedex France 33000
    34 Novartis Investigative Site Bron France 69677
    35 Novartis Investigative Site Strasbourg Cedex France 67091
    36 Novartis Investigative Site Berlin Germany 13125
    37 Novartis Investigative Site Dresden Germany 01307
    38 Novartis Investigative Site Frankfurt Germany 60488
    39 Novartis Investigative Site Gerlingen Germany 70839
    40 Novartis Investigative Site Grosshansdorf Germany 22947
    41 Novartis Investigative Site Koeln Germany 51109
    42 Novartis Investigative Site Ulm Germany 89081
    43 Novartis Investigative Site Heraklion Crete Greece 711 10
    44 Novartis Investigative Site Thessaloniki Greece 57001
    45 Novartis Investigative Site Torokbalint Pest Hungary 2045
    46 Novartis Investigative Site Ramat Gan Israel 52621
    47 Novartis Investigative Site Lucca LU Italy 55100
    48 Novartis Investigative Site Rozzano MI Italy 20089
    49 Novartis Investigative Site Aviano PN Italy 33081
    50 Novartis Investigative Site Nagoya Aichi Japan 464 8681
    51 Novartis Investigative Site Himeji Hyogo Japan 670-8520
    52 Novartis Investigative Site Yokohama-city Kanagawa Japan 241-8515
    53 Novartis Investigative Site Chuo ku Tokyo Japan 104 0045
    54 Novartis Investigative Site Osaka Japan 545-8586
    55 Novartis Investigative Site Amman Jordan 11941
    56 Novartis Investigative Site Seoul Seocho Gu Korea, Republic of 06591
    57 Novartis Investigative Site Seoul Korea, Republic of 03722
    58 Novartis Investigative Site Seoul Korea, Republic of 05505
    59 Novartis Investigative Site Ashrafieh Lebanon 166830
    60 Novartis Investigative Site Amsterdam Netherlands 1081 HV
    61 Novartis Investigative Site Groningen Netherlands 9713 GZ
    62 Novartis Investigative Site Maastricht Netherlands 6229 HX
    63 Novartis Investigative Site Gdansk Poland 80 952
    64 Novartis Investigative Site Rzeszow Poland 35-021
    65 Novartis Investigative Site Warszawa Poland 02 781
    66 Novartis Investigative Site Pushkin Saint Petersburg Russian Federation 196603
    67 Novartis Investigative Site St Petersburg Russian Federation 197758
    68 Novartis Investigative Site Singapore Singapore 169610
    69 Novartis Investigative Site Malaga Andalucia Spain 29010
    70 Novartis Investigative Site Badalona Catalunya Spain 08916
    71 Novartis Investigative Site Valencia Comunidad Valenciana Spain 46014
    72 Novartis Investigative Site La Coruna Galicia Spain 15006
    73 Novartis Investigative Site Madrid Spain 28034
    74 Novartis Investigative Site Madrid Spain 28040
    75 Novartis Investigative Site Madrid Spain 28041
    76 Novartis Investigative Site Madrid Spain 28222
    77 Novartis Investigative Site Tainan Taiwan 70403
    78 Novartis Investigative Site Taipei Taiwan

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03626545
    Other Study ID Numbers:
    • CACZ885V2301
    • 2018-002480-26
    First Posted:
    Aug 13, 2018
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    ACZ885
    canakinumab
    docetaxel
    NSCLC
    Non Small Cell Lung Cancer
    Carcinoma
    IL-1β
    PD-(L)1
    CANOPY
    CANOPY-2
    second or third line therapy
    PD-(L)1 inhibitors
    platinum-based chemotherapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Dec 28, 2021