Phase II trial of oral vinorelbine in a population of patients with lung cancer with an EGFR mutation, after failure to treatment with TKI in first line.
- Conditions
- Patients with: -Histologically or cytologically confirmed NSCLC (stage IIIB or IV) and -epidermal growth factor receptor (EGFR) positive mutation and -previously treated with tyrosine kinase inhibitor (gefitinib or erlotinib)MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003361-18-AT
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- Patients > or = 18 years.
- Histologically or cytologically confirmed NSCLC.
- Patients with epidermal growth factor receptor (EGFR) positive mutation.
- Patients progressing or relapsing after treatment with EGFR tyrosine kinase inhibitors but a minimum of 2 weeks must have elapsed prior to start of study treatment.
- Performance status KPS > or = 70% (ECOG/WHO PS 0-1).
- Stage IIIB (with supra-clavicular nodal metastases), stage IV.
- Life expectancy more than 12 weeks.
- Adequate bone marrow, hepatic and renal functions:
Neutrophils > or = 2.0 x 10^9/l, Platelets > or = 100 x 10^9/l, Haemoglobin > or = 10.0 g/dL;
Total bilirubin < or = 1.5 x ULN (Upper Limit of Normal), Transaminases (ALT, AST) < 2.5 x ULN, Alkaline Phosphatases < 5 x ULN;
Calculated creatinine clearance > or = 40 ml/min (Cockcroft and Gault formula).
- Prior therapy:
Chemotherapy: patient must not have had systemic chemotherapy or
immunotherapy (monoclonal antibody);
Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area. A minimum of 4 weeks must have elapsed prior to start of study treatment.
- Presence of at least one measurable lesion (measured in at least one dimension) which has not been previously irradiated (RECIST criteria – version 1.1). Physical examination and ultrasound will not be considered as objective tumour assessments.
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have
a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
- Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment.
- The patient must have access to social insurance according to local regulations.
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27
Patients with at least one of the following criteria will not be included:
- Known hypersensitivity to the study drug or to drugs with similar chemical structures.
- Participation in another clinical trial with any experimental drug within the 30 days before registration and/or during the study.
- Any important factor likely to modify drug absorption (e.g. surgery of the gastrointestinal tract, significant malabsorption syndrome or disease affecting the gastrointestinal tract function).
- Previous radiotherapy in the only site used to assess response.
- Clinically relevant or unstable systemic disease making implementation of the protocol difficult.
- Active central nervous system disorder, brain metastasis or leptomeningeal involvement.
- Symptomatic neuropathy (sensory) > or = grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2).
- Weight loss > 10% within the previous 3 months.
- Long term oxygen therapy.
- Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
- Women if pregnant or lactating or with positive pregnancy test at inclusion;
- Women of childbearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment.
- Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential.
- Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval > 5 years.
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