Skip to main content
OpenTrials
Completed

NCT Number: NCT00883480

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ico-Hospital Universitarios Germans Trias I Pujol, Badalona, Barcelona, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

Docetaxel 75 mg/day 1 x 4 cycles

Other names: Taxotere

Cisplatin

Drug

Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles

Other names: Platinol

Gemcitabine

Drug

Cisplatin 75 mg/ day 1 x 4 cycles

Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

Other names: Gemzar

Erlotinib

Drug

Erlotinib 150 mg/day x 21 days

Other names: Tarceva

Primary outcomes

  1. Tumoral Response (RECIST criteria)

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spanish Lung Cancer Group

Other

Registry information

Official study title

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

Acronym: SLAT

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 17, 2009
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.