Patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutations MedDRA version: 21.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GIOTRIF - 40 MG - COMPRESSA RIVESTITA CON FILM - BLISTER DIVISIBILE (PVC/PVDC) 28X1 COMPRESSE
Product Name: GIOTRIF 40 MG
Product Code: [GIOTRIF 40 MG]
Pharmaceutical Form: Coated tablet
I
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 IIIa NSCLC Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution’s testing methodology. male or female patients age =18 years Adequate organ function, defined as all of the following: Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor). Platelet count >75,000/mm3 Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: Patients with metastatic or advanced lung cancer not suitable for surgery are excluded. Patients that had received previous therapy for lung cancer (es. EGFR tyrosine kinase inhibitor (TKI), chemotherapy, radiotherapy) Patients are excluded if they had another cancer diagnosis in the last 5 years excepted adeguately treated non melanoma skin cancer or in situ cervical cancer major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial known hypersensitivity to afatinib (Giotrif®) or any of its excipients history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3 (Refer to Appendix 10.2), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment. are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential ; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of safety for the trial drug requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 that can not be stopped for the duration of trial participation presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn’s disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment. Knowed active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-tumor efficacy of afatinib, in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC), measured as objective response rate (ORR) by pathological down-staging and pathological complete response.;Secondary Objective: To assess secondary measures of clinical efficacy including time to relapse (TTR), time to progression (TTP) and overall survival (OS). To assess the safety and tolerability of afatinib in this subset of patients with NSCLC.;Primary end point(s): To assess the anti-tumor efficacy of afatinib, in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutation, measured as objective response rate (ORR) by pathological down-staging and pathological complete response.;Timepoint(s) of evaluation of this end point: at the end of the treatment period and after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess secondary measures of clinical efficacy including time to relapse (TTR), time to progression (TTP) and overall survival (OS), to assess the safety and tolerability of afatinib in this subset of patients with NSCLC.;Timepoint(s) of evaluation of this end point: during the whole treatment period (3 periods. of 28 days each). After the end of treatment every 3 months for the first 2 years and every 6 months for the following 3 years. | — |
Countries
Italy
Contacts
Public ContactUFFICIO STUDI CLINICI E ATTIVITA' R
ISTITUTO EUROPEO DI ONCOLOGIA
Outcome results
None listed