The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.
The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma. As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments. After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (\<6 months versus \>6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
VUmc Medical Center
Amsterdam, North Holland, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
progression free survival
Time frame: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
quantitative and qualitative adverse events
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
Time frame: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
response rates
Time frame: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
duration of response
Time frame: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
overall survival
Evaluation of overall survival (OS)
Time frame: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
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