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Clinical Trials List

Protocol NumberCACZ885U2301
NCT Number(ClinicalTrials.gov Identfier)NCT03631199
Completed

2018-12-07 - 2024-12-31

Phase III

Terminated6

ICD-10C34

Malignant neoplasm of bronchus and lung

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Jih-Hsiang Lee Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chi-Lu Chiang Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Completed

Audit

None

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Completed

Audit

None

Principal Investigator Chong-Jen Yu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Condition/Disease

Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects

Objectives

Primary Objective(s) Safety run-in part: • To determine the recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy. Double-blind, randomized, placebo-controlled part: • To compare progressive free survival (PFS) between the two treatment arms • To compare overall survival (OS) between the two treatment arms. Secondary Objectives Safety run-in part: • To characterize the pharmacokinetics of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy • To characterize the safety and tolerability of canakinumab in combination with pembrolizumab plus platinum-based doublet chemotherapy • To characterize the immunogenicity (anti-drug antibodies) of canakinumab and pembrolizumab • To assess the preliminary clinical anti-tumor activity (overall response rate, disease control rate and duration of response) of canakinumab in combination with pemrolizumab plus platinum-based doublet chemotherapy Double-blind, randomized, placebo-controlled part: • To evaluate overall response rate (ORR), disease control rate (DCR), time to response (TTR) and duration of response (DOR) • To characterize the safety profile of the two treatment arms. • To characterize the pharmacokinetics of canakinumab, pembrolizumab and chemotherapy • To characterize the immunogenicity (anti-drug antibodies, ADA) of canakinumab and pembrolizumab. • To assess PROs in the two treatment arms

Test Drug

ACZ885 (canakinumab)

Active Ingredient

ACZ885 (canakinumab)

Dosage Form

Solution for injection in pre-filled syringe

Dosage

50mg/0.5ml, 150mg/1ml

Endpoints

Efficacy assessments
• Radiological tumor assessments by investigator (RECIST 1.1 and immune
RECIST): At screening and every 6 weeks (for the first 12 weeks), then every 9
weeks (for the next 21 weeks) and every 12 weeks thereafter
• Survival phone calls: every 12 weeks after safety and efficacy follow-up period

Inclution Criteria

Key Inclusion criteria
• Histologically confirmed locally advanced or metastatic NSCLC
• Measurable disease by RECIST 1.1
• Known PD-L1 status
• ECOG performance status (PS) 0 or 1

Exclusion Criteria

Key Exclusion criteria
• Previous immunotherapy or treatment with IL-1β inhibitor.
• Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations and/or
anaplastic lymphoma kinase (ALK) rearrangement
• History of severe hypersensitivity reaction to monoclonal antibodies, platinum
containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of
these drugs.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    627 participants

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