Metastatic non-squamous non-small cell lung cancer Metastatic Non-squamous non-small cell lung cancer
Conditions
Interventions
Sponsors
Hôtel-Dieu de France University Hospital
Hotel Dieu de France
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion 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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: 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;Timepoints: cross-sectional, one-time assessment;Measure: proportion, counts and measures;Name: Proportion of patients in the different oncogenic driver mutation percent brackets;Timepoints: cross-sectional, one-time assessment;Measure: proportion, counts and measures;Name: Proportion of patients with non-activating mutations ;Timepoints: cross-sectional, one-time assessment;Measure: proportion, counts and measures;Name: Proportion of patients whose treatment will be based on the molecular biomarker profile;Timepoints: cross-sectional, one-time assessment;Measure: proportion, counts and measures | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: 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;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: proportion, counts and measures;Name: Proportion of patients with SD, at 3, 6 and 12 months after treatment initiation;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: proportion, counts and measures;Name: Proportion of patients with PD at 3 months, 6 months and 12 months after treatment initiation;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: proportion, counts and measures;Name: PFS estimated by the Kaplan-Meier method;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: duration;Name: Description of AEs and ADRs reported during the study;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: counts and percentages;Name: Proportion of patients who discontinued treatment due to safety concerns;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: proportion, counts and measures;Name: Time to treatment discontinuation;Timepoints: 3, 6 and 12 months after treatment initiation;Measure: duration | — |
Countries
Lebanon
Contacts
Public ContactVirginia El Khoury
Principle Investigator
Outcome results
None listed