Trial with erlotinib and bevacizumab in patients with advanced non-small cell lung cancer harboring specific gene changes in the epithelial growth factor receptor

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

Age = 18 years - ECOG performance status 0-2 - Adequate haematological function: haemoglobin > 9 g/dL, neutrophils count >1.5×109/L, platelet count > 100 × 109/L - Adequate coagulation: INR = 1.5 - Adequate liver function: Total bilirubin < 1.5 × ULN, ALT and/or AST < 2.5 ×ULN, alkaline phosphatase < 5 ULN, except in the presence of exclusive bone metastases and in the absence of any liver disorder. - Adequate renal function: Calculated creatinine clearance ? 50 mL/min (Cockroft-Gault) and proteinuria < 2+ (dipstick). - Oral swallowing capability, patient capable of proper therapeutic compliance, and accessible for correct follow-up. - Life expectancy of at least 2 months. - Women of childbearing age, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before beginning treatment. - All sexually active men and women of childbearing age must use an effective contraceptive method during the study treatment and for a period of at least 12 months following the last administration of trial drugs. - Written Informed Consent (IC) must be signed and dated by the patient and the investigator prior to any trial-related intervention for a) trial treatment b) tissue submission for central review and central EGFR testing Disease characteristics - Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC). - TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease). - Measurable or evaluable disease (according to RECIST 1.1 criteria). - Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R). - Patients with asymptomatic and stable cerebral metastases
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

- Patients with increased risk of bleeding, defined by: - major surgery or significant traumatic injury within 28 days prior to inclusion - minor surgery (including permanent catheter insertion) within 24 hours prior to first treatment with bevacizumab - history or evidence of bleeding diathesis or hereditary coagulopathy - history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion) - evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels - uncontrolled hypertension (systolic blood pressure > 150 mm Hg and / or diastolic > 100 mm Hg) - Patients with clinically significant cardiovascular diseases, including - cerebral vascular accident (<6 months before inclusion) - acute myocardial infarction (<6 months before inclusion) - unstable angina - congestive heart failure class > NYHA II - serious cardiac arrhythmia requiring medication during the study and which could interfere with regularity of study treatment or is not controlled with medication.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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