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Trial details
LUNG Study
Current status:
Approved
|
Date registered:
29/10/2024
|
Date last updated:
19/08/2024
Trial version(s)
Current: 15/12/2023
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Main Information
Primary registry identifying number
LBCTR2024015481
Protocol number
ML44926
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
06/12/2023
Primary sponsor
Hôtel-Dieu de France University Hospital
Primary sponsor: Country of origin
Lebanon
Public title
LUNG Study
Acronym
Scientific title
A Biomarker-Driven Precision Management of Lebanese Patients with Previously Untreated Metastatic Non-Squamous Non-Small Cell LunG Cancer
Acronym
Brief summary of the study: English
A Biomarker-Driven Precision Management of Lebanese Patients with Previously Untreated Metastatic Non-Squamous Non-Small Cell LunG Cancer – LUNG study Protocol number: ML44926 Lung cancer is the most common cancer worldwide and is still responsible for most cancer deaths. In Lebanon, more than 1000 cases of lung cancer are diagnosed each year. The Lebanese National Cancer Registry showed that Lebanon has the highest incidence of lung cancer in females and the second highest for males in the MENA region. The high cigarette and water-pipe consumption rate among the Lebanese population plays a key role, in addition to several other risk factors. For decades, cytotoxic chemotherapy has been the cornerstone of management of metastatic non- squamous non-small cell lung cancer (NS-NSCLC). The recognition of specific somatic ‘driver’ mutations in NSCLC has transformed both the treatment and outcomes for patients with advanced-stage lung cancer. The current two-step study will report on the prevalence of a plethora of tumor biomarkers (screening period). A specific set of activating mutations will characterize patients who will be offered participation in the treatment phase of the study, a parallel-arm umbrella trial that will assess the efficacy and safety of two orally administered precision medicine treatments (alectinib and entrectinib).
Brief summary of the study: Arabic
إعتماد الطّب الدقيق بحسب الواصمات الحيوية لمعالجة سرطان الرئة غير صغير الخلايا المنتشر الذي لم يتمَّ علاجه سابقًا لدى المرضى اللّبنانيين – دراسة LUNG البروتوكول رقم: ML44926 يُعدّ سرطان الرئة أكثر أنواع السرطان شيوعًا في جميع أنحاء العالم ولا يزال مسؤولاً عن معظم الوفيات الناجمة عن السرطان. في لبنان، يتمّ تشخيص أكثر من ١٠٠٠ حالة سرطان الرئة كل عام. أظهر السجل الوطني اللبناني للسرطان أن لبنان يسجّل أعلى معدّل للإصابة بسرطان الرئة بين الإناث وثاني أعلى معدل بين الذكور في منطقة الشرق الأوسط وشمال أفريقيا. ويلعب إرتفاع معدّل إستهلاك السجائر والشيشة بين اللبنانيين دوراً رئيسياً، بالإضافة إلى العديد من عوامل الخطر الأخرى. لطالما كان العلاج الكيميائي هو أساس علاج سرطان الرئة ذو الخلايا غير الحرشفية غير الصغيرة النقيلي. أدّى اكتشاف بعض الوصمات الحيويّة المحدّدة في سرطان الرئة غير صغير الخلايا إلى تغيير كل من العلاج والنتائج للمرضى الذين يعانون من سرطان الرئة في مرحلة متقدمة. ستقدّم الدراسة الحالية المكوّنة من خطوتين تقريرًا عن مدى انتشار عدد كبير من الوصمات الحيويّة للورم (فترة فحص الوصمات الحيويّة). أمّا المرضى ذوو الورم الذي يحتوي على وصمات حيويّة محدّدة في هذه الدراسة فسيُعرض عليهم المشاركة في مرحلة العلاج من الدراسة، وهو بحث من شأنه تقييم فعالية وسلامة إثنين من علاجات الطب الدقيق التي يتمّ تناولها عن طريق الفم (الألكتينيب والإنتركتينيب).
Health conditions/problem studied: Specify
Metastatic non-squamous non-small cell lung cancer
Interventions: Specify
Alectinib and Entrectinib
Key inclusion and exclusion criteria: Inclusion criteria
The patient must meet all the following criteria to be enrolled in the study: 1. The patient is ≥ 18 years of age. 2. The patient has signed the ICF. 3. Diagnosis of pathologically confirmed metastatic NS-NSCLC, for which no treatment has yet been administered (i.e. newly diagnosed metastatic NS-NSCLC). 4. Measurable NS-NSCLC metastatic lesions. 5. Karnofsky performance status ≥ 60 or ECOG performance status 0-2. 6. If patient has brain metastasis, they must have been stable for at least 4 weeks. 7. The patient is willing to and capable of taking the study drug by mouth. 8. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
Patients meeting any of the following exclusion criteria must not be enrolled in the study: 1. The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug. 2. The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, uncontrolled seizure disorder, uncontrolled hypertension). Patients with controlled diabetes (at the physician’s discretion) will be allowed. 3. The patient is pregnant (confirmed by serum Beta-HCG if applicable), is breastfeeding or is not using adequate contraception (for patients of child-bearing potential). 4. The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants). 5. The patient from a given study arm has already received the same therapy as the clinical trial. The eligibility criteria have been broadened to allow more patients to benefit from the biomarker screening phase of the LUNG trial. However, patients who are determined to harbor an actionable mutation within the scope of this study will be further evaluated to determine whether they are candidates for the treatment, at the discretion of the investigator. The investigator might assess the patients for hematologic function, hepatic function, renal function, and other parameters, before allowing them to join the treatment phase of this trial.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Non-randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
2 to 3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Europe, USA, Lebanon
Name of IMP
Alectinib and Entrectinib
Year of authorization
2017
Month of authorization
11
Type of IMP
Others
Type of IMP: Specify
Tyrosine kinase inhibitor
Pharmaceutical class
Tyrosine kinase inhibitor
Therapeutic indication
first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who express biomarkers of interest, targeted by alectinib or entrectinib.
Therapeutic benefit
It is expected, based on promising clinical trials, that the precision therapies will improve prognosis and prolong survival
Biospecimen retention
Samples with DNA**
Biospecimen description
Archived biopsies or recently obtained biopsies from the lung tumor will be sent to the Jacques Loiselet Center for Medical Genetics and Genomics at the Saint Joseph University in Beirut. This laboratory will determine the presence of biomarkers in tumor samples, using the AVENIO Tumor Tissue CGP Kit for genomic testing of solid tumors
Target sample size
162
Actual enrollment target size
202
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
02/01/2024
Date of study closure: Type
Anticipated
Date of study closure: Date
31/03/2026
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
Patients will not be identified by their names or date of birth on the case report form or other study documentation submitted to the sponsor; instead patients will be given a unique identification number as soon as they have signed the informed consent form (ICF). For safety reasons, the investigators will maintain a ‘patient identification log’ with the name and contact details of each patient. This log and the signed ICFs will be kept in strict confidence by the investigators
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
Roche Lebanon
Secondary Sponsors
Name
Hotel Dieu de France
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Virginia
El Khoury
Hotel Dieu de France
Lebanon
00961 1 604 000
felkarak@yahoo.com
Principle Investigator
Scientific
Fadi
ElKarak
Hotel Dieu de France
Lebanon
009611421229
virginia.elkhoury@usj.edu.lb
Secretary of the Ethics Committee
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France
Dr. Fadi El Karak
Oncologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
06/01/2024
Michel Scheuer
cue@usj.edu.lb
009611421229
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Lung cancer
Carcinoma in situ of other specified sites (D09.7)
Metastatic Non-squamous non-small cell lung cancer
Interventions
Intervention
Description
Keyword
Alectinib
Total daily dose of 1200 mg: 600 mg (4 tablets) taken twice daily Must be taken with food
150 mg
entrectininb
Total daily dose of 600 mg (3 tablets) taken once daily Taken with or without food Should not be taken with grapefruit or grapefruit juice
200 mg
Primary Outcomes
Name
Time points
Measure
Proportion of oncogenic driver mutations of interest: ALK rearrangement, NTRK gene fusion, MET alteration (skip mutation at Exon 14), EGFR mutation, ROS1 gene fusion, RET gene fusion, HER-2 (ERBB2) mutations, BRAF mutations, and potentially other biomarkers
cross-sectional, one-time assessment
proportion, counts and measures
Proportion of patients in the different oncogenic driver mutation percent brackets
cross-sectional, one-time assessment
proportion, counts and measures
Proportion of patients with non-activating mutations
cross-sectional, one-time assessment
proportion, counts and measures
Proportion of patients whose treatment will be based on the molecular biomarker profile
cross-sectional, one-time assessment
proportion, counts and measures
Key Secondary Outcomes
Name
Time points
Measure
Proportion of patients achieving CR (disappearance of all target lesions), PR (≥30% decrease in the sum of the longest diameter of target lesions) and OR = CR + PR; according to RECIST v1.1 (23, 24) for target lesions and assessed by imaging at 3 months, 6 months and 12 months after treatment initiation
3, 6 and 12 months after treatment initiation
proportion, counts and measures
Proportion of patients with SD, at 3, 6 and 12 months after treatment initiation
3, 6 and 12 months after treatment initiation
proportion, counts and measures
Proportion of patients with PD at 3 months, 6 months and 12 months after treatment initiation
3, 6 and 12 months after treatment initiation
proportion, counts and measures
PFS estimated by the Kaplan-Meier method
3, 6 and 12 months after treatment initiation
duration
Description of AEs and ADRs reported during the study
3, 6 and 12 months after treatment initiation
counts and percentages
Proportion of patients who discontinued treatment due to safety concerns
3, 6 and 12 months after treatment initiation
proportion, counts and measures
Time to treatment discontinuation
3, 6 and 12 months after treatment initiation
duration
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
Download as PDF
Save a PDF copy of the summary of the trial