Advanced NSCLC harbouring EGFR mutations (del19 or L858R). MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: AVASTIN*INFUS 1FL 400MG 16ML
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-
Sponsors
IBCSG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine progression free survival (PFS) of patients with advanced non-squamous NSCLC;Primary end point(s): Progression-free survival (PFS is defined as the time from the date of enrolment until documented progression or death, whichever occurs first);Timepoint(s) of evaluation of this end point: The final evaluation will be done within 6 months after the last visit of the last patient, approximately 54 months after the inclusion of the first patient.;Secondary Objective: To evaluate secondary measures of clinical efficacy. - To assess the safety and the tolerability of the erlotinib and bevacizumab combination. - To evaluate the correlation of BRCA1 mRNA and AEG-1 mRNA expression and T790M with progression-free survival. - To monitor EGFR mutations (including T790M) in serum longitudinally. - To evaluate molecular biomarkers related to EGFR TKI and bevacizumab. - To determine the feasibility of re-biopsies at the time of progression and geneexpression arrays for decision-making for second-line treatment - To study the feasibility of recommending customized second-line chemotherapy based on BRCA1 and AEG-1 mRNA levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) - Time to treatment failure (TTF) - Objective response (OR) - Adverse events graded according to CTCAE V4.0 - Disease control (DC) - Duration of response (DR);Timepoint(s) of evaluation of this end point: The final evaluation will be done within 6 months after the last visit of the last patient, approximately 54 months after the inclusion of the first patient. | — |
Countries
France, Germany, Greece, Ireland, Italy, Spain, Switzerland, United Kingdom
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed