Patients with advanced or metastatic (stage IIIB-IV) non small cell lung cancer who have not received prior chemotherapy will be treated with erlotinib 150 mg once a day and sorafenib 400 mg twice a day. The objectives of the study are to assess the efficacy and safety of this combination treatment. Additional exploratory study objectives are correlation of biomarkers and imaging modalities potentially predictive for response and (progression free) survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
sorafenib 400mg b.i.d oral Erlotinib 150 mg o.i.d oral
VU university medical center
Amsterdam, Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Rate of non-progression at 6 weeks
Time frame: 6 weeks
Best overall response rate
Time frame: end of study
Duration of response
Time frame: End of study
Survival
Time frame: End of study
Toxicity
Time frame: Week 1, week 3, week 6, week 9, week 12 then every 6 weeks
Prediction of early response and effects on tumor vascularisation by PET and perfusion CT scans
Time frame: Baseline, week 3 and week 6
Biomarkers for response (Proteomics, circulating cells, mutational analysis)
Time frame: Baseline, week 1, week 3 and week 6
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