Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

Study Overview
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Brief Summary
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This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

Detailed Description
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Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma

Official Title
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Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Drug: Gemcitabine
* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel | Drug: Docetaxel<br>* Docetaxel 75 mg/day 1 x 4 cycles<br>* Other names: Taxotere;Drug: Cisplatin<br>* Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles<br>* Other names: Platinol;Drug: Gemcitabine<br>* Cisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles<br>* Other names: Gemzar;|
| Experimental: 1<br>The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor | Drug: Erlotinib<br>* Erlotinib 150 mg/day x 21 days<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumoral Response (RECIST criteria) | To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1. | From date of end of experimental treatment until the date of last follow up, assessed up to 24 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | From the date of randomization to the date of last follow up or death, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC