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

Not Applicable

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Erlotinib; Drug: Cisplatin; Drug: Gemcitabine

• Registration Number: NCT00883480
• Lead Sponsor: Spanish Lung Cancer Group

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

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2008-01
• Study Completion: 2008-11
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Docetaxel	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
2	Cisplatin	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
2	Gemcitabine	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
1	Erlotinib	The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

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

Hospital Carlos Haya; 🇪🇸 Málaga, Spain