Study of Effectiveness and Safety of Canakinumab in Adult Subjects With early diagnosed Completely surgically removed Non-small Cell Lung Cancer
- Conditions
- Health Condition 1: null- completely resected (R0) non -small cell lung cancer (NSCLC)Health Condition 2: C399- Malignant neoplasm of lower respiratory tract, part unspecified
- Registration Number
- CTRI/2018/06/014392
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
establishe
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to compare the Diseasefree <br/ ><br>survival (DFS) in the canakinumab versus <br/ ><br>placebo arms as determined by local investigator <br/ ><br>assessment.Timepoint: DFS determined by local investigator assessment
- Secondary Outcome Measures
Name Time Method To compare the two treatment groups with respect to lung cancer specific survival (LCSS)Timepoint: time to definitive deterioration in patient-reported outcomes, including key symptom scores, and safety.;To determine whether treatment with canakinumab prolongs OS compared with placebo arm.Timepoint: time to definitive deterioration in patient-reported outcomes, including key symptom scores, and safety.