Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC
Brief summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Detailed description
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
Interventions
DRUGDocetaxel
Docetaxel 75 mg/day 1 x 4 cycles
DRUGCisplatin
Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
DRUGGemcitabine
Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles
DRUGErlotinib
Erlotinib 150 mg/day x 21 days
Sponsors
Spanish Lung Cancer Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age 18 years or more. * Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology). * Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included. * Tumor sample available. * A measurable lesion, as defined by RECIST criteria. * Karnofsky score 60% or more (ECOG \< 2). * Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment. * Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment. * Patients with hepatical, renal and hematology normality values. * Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood. * Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study. * Patients must be available for clinical follow-up..
Exclusion criteria
* Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent. * Severe comorbidity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumoral Response (RECIST criteria) | From date of end of experimental treatment until the date of last follow up, assessed up to 24 months] | To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From the date of randomization to the date of last follow up or death, assessed up to 24 months | Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation. |
Countries
Spain
Contacts
STUDY_CHAIRRafael Rosell, MD
ICO-HOSPITAL GERMANS TRIAS I PUJOL
Outcome results
None listed