Multicenter trial to compare erlotinib vs mono-chemotherapy in the third-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR-mutated or unknow

Phase 1

• Conditions: Third-line treatment in patients with non-small cell lung cancer (NSCLC) patients with EGFR-mutated or unknown; MedDRA version: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001207-42-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-02
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

• Histological or cytological diagnosis of NSCLC in stage IIIB -IV, according to the 7th TNM .
• State of EGFR - mutated or unknown .
• Patients who have received two prior lines of chemotherapy for advanced disease, the last of which ended at least three weeks. They are also eligible patients who have already received, in addition to 2 lines of chemotherapy; more than 1 line of treatment different from chemotherapy provided no EGFR inhibitors (see exclusion criterion 1).
• Written informed consent.
• Age = 18 years.
• Performance Status (PS ) = 2 of the ECOG scale .
• Life expectancy of at least 12 weeks.
• Is permitted radiotherapy with palliative intent before starting treatment.
• X-ray examination should be used as a baseline evaluation was performed within 28 days of the start of chemotherapy.
• Baseline hematological examinations performed within 7 days prior to enrollment , with the following values : hemoglobin = 9 g / dl , = 1.500/mm3 neutrophils , platelets = 100.000/mm3 , total bilirubin = 1.5 times the upper limit of normal , ALT , AST = 2 times the upper limit of normal , creatinine within the normal range.
• When it comes to women of childbearing age, the patient should make use of appropriate means of contraception.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

• Patients who have received prior EGFR inhibitors.
• Patients who have previously received gemcitabine (in case of non-squamous histology) or vinorelbine (in the case of squamous histology). * (See section 7.3)
• Patients with brain metastases are not controlled.
• Patients who are currently treated with experimental agents or who have interrupted a clinical study of not less than 30 days.
• Patients who have ongoing infections or uncontrolled diabetes mellitus or heart disease grade III-IV NYHA or other serious disease ..
• Patients with cancer with ALK rearrangement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified