Patients with histologically confirmed diagnosis of NSCLC pathological stages I, II or III A. Patients must have completely resected disease and may not be treated with prior chemotherapy. Patients must have fully recovered from surgery prior to initiation of study treatment. MedDRA version: 9.1 Level: LLT Classification code 10029517 Term: Non-small cell lung cancer stage I MedDRA version: 9.1 Level: LLT Classification code 10029518 Term: Non-small cell lung cancer stage II MedDRA version: 9
Conditions
Interventions
Trade Name: Nexavar 200mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
CAS Number: 4750207-59-1
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Universität Mainz, III. Medizinische Klinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically confirmed diagnosis of NSCLC UICC stages I, II or III A. • Patients must have completely resected disease (pathological R0 resection) and may not be treated with prior chemotherapy. Patients must have fully recovered from surgery prior to initiation of study treatment. • Adjuvant radiotherapy for stage III A disease is permitted given that the patient has recovered from all radiation-induced toxicities. In those patients, a complete restaging will be performed prior to enrolment into the trial. • Patients with completely resected NSCLC stage II or III A, who for medical reasons are not eligible for standard adjuvant chemotherapy consisting of a regimen of 4 cycles cisplatin/vinorelbine. • Patients with completely resected NSCLC stage II or III A, who are not willing to undergo standard adjuvant chemotherapy with 4 cycles of cisplatin/vinorelbine, are also eligible. • Age = 18 years. • ECOG performance status 0, 1 or 2. • Normal organ and marrow function defined as: a. Hematopoetic: absolute neutrophil count >1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 9 g/dL b. INR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any other histology (e.g. carcinoid tumors) or disease stages other than I to III A. • Patients who are eligible and willing to undergo standard adjuvant chemotherapy (4 cycles of cisplatin/vinorelbine). • Any prior systemic anticancer therapy including chemotherapy, targeted agents, experimental therapy or biological therapy for NSCLC. • Cardiac disease: congestive heart failure > class II NYHA, patients must not have unstable angina pectoris or new onset of angina pectoris or myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy. • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal therapy. • Known brain metastasis. Patients with symptoms should undergo CT scan/MRI of the brain to exclude brain metastasis. • Active clinically serious infections > NCI-CTCAE Grade 2. • Thrombotic or embolic events including transient ischemic attacks within the past 6 months. • Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks before first dose of study drug. • Hemorrhage/bleeding event = NCI-CTCAE Grade 3 within 4 weeks before first dose of study drug. • Serious non-healing wound, ulcer or bone fracture. • Evidence or history of bleeding diathesis or coagulopathy. • Therapeutic anticoagulation with Vitamin K antagonists such as warfarin/phenprocoumon, or with heparins or heparinoids. Low dose warfarin/phenprocoumon is permitted if INR is < 1.5. Low dose aspirin (300mg/d) is permitted. • Use of St John’s Wort or rifampicin. • Major surgery, open biopsy or significant traumatic injury within 4 weeks before first dose of study drug. • Known or suspected allergy to Sorafenib or any agent given in the course of this trial. • Previous cancer that is distinct in primary site or histology from NSCLC except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated = 3 years prior to study entry. • Concurrent cancer that is distinct in primary site or histology from NSCLC. • Substance abuse, medical or psychological condition that may interfere with the patient´s participation in the study. • Any condition that impairs patient’s ability to swallow whole pills • Any malabsorption condition • Use of Bevacizumab or any other any drugs (licensed or investigational) that target VEGF or VEGF Receptors. • Systemic treatment for lung cancer, including the use of investigational agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the 2 year progression-free survival (PFS) in patients with NSCLC (UICC stages I to III A) treated with Sorafenib following potentially curative surgery of NSCLC. ;Secondary Objective: Secondary objectives are - To determine PFS at 3 and 4 years following surgery - To determine overall survival (assessed after 3 and 4 years) - To assess the safety and tolerability of Sorafenib adjuvant treatment when administered following surgery for NSCLC, - To assess biomarkers relevant to Sorafenib response and disease state, and their correlation to clinical outcome;Primary end point(s): Progression-free survival at 2 years (PFS, time until disease progression or death from any cause) | — |
Countries
Germany
Outcome results
None listed