Clinical Trials List
Protocol NumberCACZ885V2301
NCT Number(ClinicalTrials.gov Identfier)NCT03626545
2019-02-22 - 2022-01-31
Phase III
Terminated3
ICD-10C34
Malignant neoplasm of bronchus and lung
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chi-Lu Chiang Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- 楊朝能 Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- Shang-Yin Wu Division of General Internal Medicine
- Wei-Pang Chung Division of General Internal Medicine
- Yu-Min Yeh Division of General Internal Medicine
- Jui-Hung Tsai Division of General Internal Medicine
- Wen-Pin Su Division of General Internal Medicine
- Chien-Chung Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- 林宗哲 Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 林育麟 Division of Hematology & Oncology
- 徐偉勛 醫學研究部
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Non-small Cell Lung Cancer (NSCLC)
Objectives
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.
Test Drug
Ilaris
Active Ingredient
ACZ885/Canakinumab
Dosage Form
Solution for injection in pre-filled syringe
Dosage
50mg/0.5mL, 150mg/1mL
Endpoints
Primary Outcome Measures :
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.
Secondary Outcome Measures :
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 ]
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.
Secondary Outcome Measures :
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 ]
Inclution 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.
-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.
Exclusion 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.
-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.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
240 participants
