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CTRI Number  CTRI/2018/06/014392 [Registered on: 04/06/2018] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Effectiveness and Safety of Canakinumab in Adult Subjects With early diagnosed Completely surgically removed Non-small Cell Lung Cancer  
Scientific Title of Study   A phase III, multicenter, randomized, double blind, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CACZ885T2301-Protocol Verion 00 dated 10-Nov-17  Protocol Number 
NCT03447769   ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited Trial Monitoring – GDO, GDD India Inspire- BKC, 7th floor, G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited Trial Monitoring – GDO, GDD India Inspire- BKC, 7th floor, G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited Trial Monitoring – GDO, GDD India Inspire- BKC, 7th floor, G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  02250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support
Modification(s)  
Novartis Healthcare Private Limited Trial Monitoring – GDO, GDD India Inspire- BKC, 7th floor, G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai-400051  
 
Primary Sponsor
Modification(s)  
Name  Novartis Healthcare Pvt Ltd 
Address  Novartis Healthcare Private Limited Trial Monitoring – GDO, GDD India Inspire- BKC, 7th floor, G Block, BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai-400051, Maharashtra 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Czech Republic
Egypt
France
Germany
Greece
Guatemala
Hong Kong
Hungary
India
Israel
Italy
Japan
Jordan
Lebanon
Malaysia
Mexico
Netherlands
Norway
Oman
Panama
Peru
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Singapore
Slovakia
Spain
Switzerland
Taiwan
Thailand
Turkey
United Arab Emirates
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramakant Deshpande  Asian Institute of Oncology Pvt. Ltd  Somaiya Ayurvihar – Asian Cancer Institute, Off Eastern Express Highway, Behind Everard Nagar, Somaiya Ayurvihar, Sion (E), Mumbai – 400022
Mumbai
MAHARASHTRA 		 9820422222

r.deshpande@acicancer.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer  1st floor, Dept of clinical research, Behind Shivang Auto, Mumbai Naka, Nashik-422001
Nashik
MAHARASHTRA 		 9823061929

drraj@cmccnasik.in 
Dr K Govind Babu  Healthcare Global Enterprises Limited,  #44-45/2,2nd Cross Rajaram Mohan Roy Road Exten, Double Road, Bangalore 560027
Bangalore
KARNATAKA 		 919845072940

kgblaugh@gmail.com 
Dr Ashish Joshi  Mumbai Oncocare Centre   (Unit of cell cultureCancer center Pvt Ltd) 2nd floor, Majithira Apartment, Gods Gift premises Co-op Society LTD, S. V. Road, Vileparle (W) Mumbai - 400056
Mumbai
MAHARASHTRA 		 9920767626

ashjoshi44@mocindia.co.in 
Dr Ullas Batra  Rajiv Gandhi Cancer Institute and Research Centre  2264, Research dept., old building, 3rd floor, Sector - 5, Rohini, Delhi - 110 085
New Delhi
DELHI 		 9711080001

ullasbatra@gmail.com 
Dr Bivas Biswas  Tata Medical Center  14 Major Arterial Road (EW), New Town, Rajarhat, Kolkata - 700 160, West Bengal, India.
Kolkata
WEST BENGAL 		 9663667459

bivasbiswas@gmail.com 
Dr Vijay Patil  Tata Memorial Hospital  Room no.: 304, Dept. of medical oncology, 3rd floor, Homo bhaba block, Dr. E Borges Road, Parel, Mumbai, 400012
Mumbai
MAHARASHTRA 		 912224177000

vijaypgi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
HCG Central Ethics Committee  Approved 
Institutional Ethics committee-Dr Deshpande  Approved 
Institutional Ethics committee-Dr pATIL  Approved 
Institutional Review Board RGCI  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Mumbai Oncocare Centre Institutional Ethics Committee-Dr Joshi  Approved 
Tata Medical Centre Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  completely resected (R0) non - small cell lung cancer (NSCLC), (1) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  canakinumab 200 mg  All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles. 
Comparator Agent  Placebo  All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: canakinumab 200 mg or matching placebo. The study drug will be given as subcutaneous injections on C1D1 and then every cycle (21 days) for 18 cycles. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Written informed consent must be obtained prior to any screening
procedures.
2. Age more than 18 years
3. Completely resected (R0) AJCC/UICC v. 8 stage IIA with T less than 4-5 cm
and N0 (no nodal involvement), if no adjuvant chemotherapy is given,
must be randomized within 70 days post complete surgical resection of
their NSCLC.
4. Subjects with completely resected (R0) AJCC/UICC v. 8 stages IIA,
IIB, IIIA or IIIB (T less than 5 cm N2) disease NSCLC, who received
chemotherapy and no radiation therapy must be randomized within
182 days post complete surgical resection of their NSCLC.
5. Subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA N2
(T less than or equal to 5 cm only) or stage IIIB (Tless than 5cm N2) disease who receive radiation
therapy along with chemotherapy detailed in inclusion criterion 6, must
be randomized within 259 days of complete surgical resection.
6. Adjuvant chemotherapy is mandatory with stage AJCC/UICC v. 8
stage II-IIIA and stage IIIB (T less than 5cm N2) disease for 4 cycles (21 or 28
day cycles) as per local/national guidelines (except if not tolerated, in
which case at least 2 cycles of adjuvant chemotherapy are required).
Adjuvant chemotherapy is mandatory (at least 2 cycles) for all
subjects except those who have stage IIA disease with T(less than 4-5 cm).
Chemotherapy must be cisplatin based. Combination partners may include vinorelbine, etoposide, docetaxel or gemcitabine
for any histology. For non-squamous carcinomas only, the combination partner may be pemetrexed.
7. Subjects must have recovered from all toxicities related to prior
systemic therapy to grade less than or equal to 1 (CTCAE v 4.03). Exception to this criterion: subjects with any grade of alopecia and grade 2 or lessneuropathy are allowed to enter the study.
8. Subjects must have adequate organ function including the following laboratory values at the screening visit:
Absolute neutrophil count (ANC) more than or equal to 1.5 x 109/L
Platelets more than or equal to 100 x 109/L
Hemoglobin (Hgb) more than 9 g/dL
Creatinine clearance greater than 45 ml/min using Cockcroft-Gault formula
Total bilirubin mess than or equal to 1.5 x ULN
Aspartate transaminase (AST) less than or equal to 3 x ULN
Alanine transaminase (ALT) less than or equal 3 x ULN
9. ECOG performance status (PS) of 0 or 1.
10. Willing and able to comply with scheduled visits, treatment plan and
laboratory tests. 
 
ExclusionCriteria 
Details  1. Subjects with unresectable or metastatic disease, positive microscopic
margins on the pathology report, and/or gross disease remaining at
the time of surgery.
2. Subjects who received neoadjuvant chemotherapy or neoadjuvant
radiotherapy.
3. Presence or history of a malignant disease, other than the resected
NSCLC, that has been diagnosed and/or required therapy within the
past 3 years. Exceptions to this exclusion include the following:
completely resected basal cell and squamous cell skin cancers, and
completely resected carcinoma in situ of any type.
4. History of interstitial lung disease.
5. History or current diagnosis of cardiac disease, including any of the
following:
recent myocardial infarction or coronary artery bypass graft
(CABG) surgery within last 6 months,
uncontrolled congestive heart failure,
unstable angina (within last 6 months),
clinically significant (symptomatic) cardiac arrhythmias (e.g.,
sustained ventricular tachycardia, and clinically significant second
or third degree AV block without a pacemaker).
6. Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting cycle 1
day 1 or subjects who have not recovered from radiotherapy-related
toxicities. Radiation therapy is suggested, but not required to be given
to subjects with completely resected (R0) AJCC/UICC v. 8 stage IIIA
or IIIB with T greater than 5cm N2 disease, (mediastinal radiation).
7. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic)
within 4 weeks prior to randomization or who have not recovered from
side effects of such procedure. Video-assisted thoracic surgery
(VATS) and mediastinoscopy will not be counted as major surgery and
subjects can be enrolled in the study greater than or equal to 1 week after the procedure.
8. Uncontrolled diabetes as defined by the investigator.
9. Known active or recurrent hepatic disorder including cirrhosis, hepatitis
B and C (positive or indeterminate central laboratory results).
10. Subjects with a history of tuberculosis (TB) infection, active or latent,
or one of the following risk factors:
History of any of the following: residence in a
congregate setting: jail or prison, homeless shelter or
chronic care facility, substance abuse (injected or noninjected);
health care workers with unprotected
exposure to subjects who are at high risk of TB or
subjects with TB disease before identification and
correct airborne precautions of the infected subject.
Close contact (i.e. sharing the same air space in a household or other enclosed environment for
prolonged period (days or weeks, not hours or
Novartis Confidential Page 14
Oncology Protocol (Version No. 00) Protocol No. CACZ885T2301 minutes) with a person with active TB disease within
the past 12 months. Evidence of TB infection, active or latent, at screening
as determined by purified protein derivative (PPD)
skin test and /or QuantiFERON®-TB Gold (QFT-g)
assay as defined by country guidelines (refer to
Determination of TB status to be further defined in full
protocol).
If presence of TB, active or latent, is
established then treatment for TB (according
to country guidelines for TB treatment or TB
treatment must be completed before
treatment with immunomodulating drugs)
must have been completed prior to screening
as per country guidelines.
In the absence of country TB (active or
latent) guidelines, the following has been
demonstrated: TB has been adequately
treated with antibiotics, cure can be
demonstrated, and risk factors resulting in
TB exposure and contracting TB have been
removed (e.g. subject no longer lives in highrisk
TB exposure setting).
11. Subjects with suspected or proven immunocompromised state,
including:
Human Immunodeficiency Virus (HIV) infections
including those receiving ant-viral therapy.
Those with any other medical condition, which in the opinion of the investigator places the subject at an unacceptable risk for participation in immunomodulatory therapy
Those requiring systemic or local treatment with any immune modulating agent in doses with systemic
effects e.g. high dose oral of intravenous steroids (>20 mg prednisone orally daily for >14 days, > 5 mg prednisone orally daily or the equivalent dose of intravenous steroid or methotrexate >15 mg weekly.
Important clarification: Topical, inhaled or local steroid use in doses that are not considered to cause systemic effects are permitted.
12. Live vaccination within 3 months prior to first dose of study drug.
13. Prior treatment with canakinumab or drugs of a similar mechanism of
action (IL-1beta inhibitor).
14. History of hypersensitivity to canakinumab or drugs of a similar class.
15. Subjects who have received an investigational drug or device within 30
days prior to first dose of study drug or those who are expected to
participate in any other investigational drug or device during the
conduct of the study.
16. Subjects receiving any biologic drugs targeting the immune system (for
example, TNF blockers, anakinra, rituximab, abatacept, or
tocilizumab).
17. Any medical condition resulting in a life expectancy of less than 5 years, other than the risk for recurrent lung cancer.
18. Pregnant or nursing women, where pregnancy is defined as the state
of a female after conception and until the termination of gestation,
confirmed by a positive hCG laboratory test
19. Women of child-bearing potential, defined as all women physiologically
capable of becoming pregnant, unless they are using highly effective
methods of contraception during dosing and for 130 days(approximately five terminal half-lives) after stopping medication.
Highly effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual
lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal
are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at
least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject Use of oral, injected or implanted hormonal methods of
contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1 percent), for
example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study
treatment.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous)
amenorrhea with an appropriate clinical profile (i.e. age appropriate,
history of vasomotor symptoms) or have had surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy, or
tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment is she considered not of child bearing potential. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to compare the Diseasefree
survival (DFS) in the canakinumab versus
placebo arms as determined by local investigator
assessment. 		 DFS determined by local investigator assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether treatment with canakinumab prolongs OS compared with placebo arm.  time to definitive deterioration in patient-reported outcomes, including key symptom scores, and safety.  
To compare the two treatment groups with respect to lung cancer specific survival (LCSS)  time to definitive deterioration in patient-reported outcomes, including key symptom scores, and safety.  
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "1382"
Final Enrollment numbers achieved (India)="7" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/06/2018 
Date of Study Completion (India) 22/09/2022 
Date of First Enrollment (Global)  01/02/2018 
Date of Study Completion (Global) 07/09/2023 
Estimated Duration of Trial   Years="7"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   publication not yet provided 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A phase III, multicenter, randomized, double blind, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II-IIIA and IIIB (T5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)           

target sample size for India is 40 patients

FPFV will be in May 2018

 
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