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

Spanish Lung Cancer Group

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Erlotinib; Drug: Cisplatin; Drug: Docetaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00883480

SLAT

Details and patient eligibility

About

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

Full description

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

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

2

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Docetaxel

Drug: Cisplatin

1

Experimental group

Description:

The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor

Treatment:

Drug: Erlotinib