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Trial details
Trial details
Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Current status:
Approved
|
Date registered:
09/10/2020
Trial version(s)
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
History: 25/12/2019
Current: 25/12/2019
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Main Information
Primary registry identifying number
LBCTR2019121368
Protocol number
CINC280A2201
MOH registration number
4331/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This study already started before LBCTR registry and still ongoing
Date of registration in national regulatory agency
15/05/2015
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharma Services Inc.
Public title
Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer
Acronym
Scientific title
A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)
Acronym
Brief summary of the study: English
A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
Brief summary of the study: Arabic
دراسة مرحلة ثانية متعددة المراكز لمثبّط cMET الفموي INC280 لدى المرضى البالغين المصابين بسرطان الرئة غير ذي الخلايا الصغيرة المتقدّم من النوع الحاد EGFR
Health conditions/problem studied: Specify
advanced non-small cell lung cancer (NSCLC)
Interventions: Specify
INC280 (capmatinib)
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: •Stage IIIB or IV NSCLC (any histology) at the time of study entry •Histologically or cytologically confirmed diagnosis of NSCLC that is: 1.EGFR wt as per patient standard of care by a validated test 2.AND ALK-negative rearrangement as part of the patient standard of care by a validated test 3.AND (by central assessment) either: ◾Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or ◾Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or ◾Cohort 3: Pre-treated patients with cMET GCN < 4, or ◾Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN, or ◾Cohort 5: Treatment-naïve patients with cMET dysregulation, or ◾Cohort 6: Pre-treated patients with either cMET GCN ≥ 10 without cMET mutations or cMET mutations regardless of cMET GCN, or ◾Cohort 7: Treatment-naïve patients with cMET mutations regardless of cMET GCN •To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease •To be eligible for Cohort 6, patients must have failed one prior line of systemic therapy for advanced/metastatic disease •To be eligible for Cohort 5 and Cohort 7, patients must not have received any systemic therapy for advanced/metastatic disease •At least one measurable lesion as defined by RECIST 1.1 •Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study. •Patients must have adequate organ function •ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion criteria may apply
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion Criteria: •Prior treatment with crizotinib, or any other cMET or HGF inhibitor •Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations •Patients with characterized ALK-positive rearrangement •Clinically significant, uncontrolled heart diseases. •Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study: ◦Strong inducers of CYP3A4 •Impairment of GI function or GI disease that may significantly alter the absorption of INC280 •Patients receiving treatment with any enzyme-inducing anticonvulsant •Applicable to Cohorts 1-4 and Cohort 6 only: Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose •Pregnant or nursing women •Women of child-bearing potential, unless they are using highly effective methods of contraception •Sexually active males unless they use a condom during intercourse •Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis Other protocol-defined exclusion criteria may apply
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
No
Name of IMP
INC280 (capmatinib)
Type of IMP
Others
Type of IMP: Specify
Targeted Therapy
Pharmaceutical class
adenosine triphosphate (ATP) competitive, reversible inhibitor of the c-MET receptor tyrosine kinase
Therapeutic indication
Adult male and female patients with EGFR wt (for exon 19 deletions and exon 21 L858R substitution mutations), ALK-negative rearrangement, advanced (stage IIIB or IV) NSCLC who have received one or two prior lines of systemic therapy for advanced/metastatic disease.
Therapeutic benefit
Overall Response Rate (ORR)
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples shipped to central laboratory.
Target sample size
3
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
20/04/2016
Date of study closure: Type
Actual
Date of study closure: Date
25/12/2020
Recruitment status
Complete
Date of completion
12/02/2020
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02414139?cond=Lung+Cancer&cntry=LB&draw=2
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical Trials .gov
NCT02414139
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Fadi
Farhat
Saida
Lebanon
03-753155
drfadi.trials@gmail.com
Hammoud Hospital University Medical Center
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1512002 # 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Joseph
Kattan
Beirut
Lebanon
03-635913
jkattan62@hotmail.com
Hotel Dieu De France
Public
Arafat
Tfayli
Beirut
Lebanon
71-194294
Arafat.tfayli@aub.edu.lb
American University Of Beirut Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Fadi Farhat
Hematology- Oncology
Approved
American University of Beirut Medical Center
Arafat Tfayli
Hematology- Oncology
Approved
Hotel Dieu De France
Joseph Kattan
Hematology- Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
14/09/2015
Fuad Ziyadeh
fz05@aub.edu.lb
961 (0) 1 350 000 ext:5445
Hotel Dieu de France
17/04/2015
Nancy Alam
nancy.alam@usj.edu.lb
961 (0) 1 421000 ext 2335
Hammoud Hospital University Medical Center
02/06/2017
Ahmad Zaatari
zaatari@hammoudhospital.com
961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Lebanon
Argentina
Austria
Brazil
Canada
China
France
Germany
Italy
Japan
Mexico
Netherlands
Norway
Turkey
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
advanced non-small cell lung cancer (NSCLC)
Bronchus or lung, unspecified (C34.9)
advanced non-small cell lung cancer (NSCLC)
Interventions
Intervention
Description
Keyword
Lab tests, ECG, Physical Exam , ICF
Lab tests, ECG, Physical Exam , ICF
Lab tests, ECG, Physical Exam , ICF
Primary Outcomes
Name
Time points
Measure
Overall Response Rate (ORR)
18 weeks
18 weeks
Key Secondary Outcomes
Name
Time points
Measure
Duration of Response (DOR)
18 weeks
18 weeks
Progression-free Survival
18 weeks
18 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
ERT cyber incident with no impact on patients in Lebanon
09/10/2020
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