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

June 8, 2022 updated by: Spanish Lung Cancer Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • Hospital Carlos Haya
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Ico-Hospital Universitarios Germans Trias I Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
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
Docetaxel 75 mg/day 1 x 4 cycles
Other Names:
  • Taxotere
Drug: Cisplatin
Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
Other Names:
  • Platinol
Drug: Gemcitabine

Cisplatin 75 mg/ day 1 x 4 cycles

Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles

Other Names:
  • Gemzar
Experimental: 1
The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor
Drug: Erlotinib
Erlotinib 150 mg/day x 21 days
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Lung Cancer Group

Investigators

  • Study Chair: Rafael Rosell, MD, ICO-HOSPITAL GERMANS TRIAS I PUJOL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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