This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC. The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. For sample size calculation a 2 year PFS of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated for the intervention group. These estimates are based on the actual PFS and overall survival (OS) of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to published international results, and the improvement of PFS achieved by 4 cycles of cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Sorafenib will be administered as oral formulation (200 mg tablets) at a dose of 400 mg twice daily starting 28 to 42 days after surgery or surgery plus adjuvant radiotherapy. The dose may be adjusted based on individual toxicities following a predetermined dose reduction schedule. Sorafenib therapy will be continued for 48 months, or until disease progression, patient refusal or intolerable toxicity, whichever comes first. Patients in remission after 48 months will be offered continued Sorafenib treatment in a roll-over study.
SIRN investigational trial site
Essen, Germany
SIRN investigational trial site
Halle, Germany
SIRN investigational trial site
Löwenstein, Germany
SIRN investigational trial site Johannes Gutenberg Universität
Mainz, Germany
SIRN investigational trial site Katholisches Klinikum
Mainz, Germany
SIRN investigational trial site
Rotenburg (Wümme), Germany
Progression-free survival (PFS) clinical and radiological assessment of remission status (RECIST criteria)
Time frame: 2 years
Progression free survival
Time frame: 3 and 4 years
Overall survival
Time frame: 3 and 4 years
Assessment of safety and tolerability of Sorafenib when administered as adjuvant treatment following surgery for NSCLC
Time frame: 2, 3 and 4 years
Assessment of biomarkers relevant to Sorafenib response and disease state, and their correlation to clinical outcome
Time frame: 4 years
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