The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).
Open randomized multicenter phase II study in patients in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology. Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity. Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
195
non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.
erlotinib 150 mg/day continuously until disease progression
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
VU medisch centrum
Amsterdam, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Progression Free Survival (PFS)
to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
Time frame: From randomisation to date of first progression or date of death, assessed up to 36 months
Number of Adverse Events
to compare relevant toxicity (CTC AE vs 3.0) in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent
Time frame: From randomisation to 30 days after EoT all AEs are collected
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Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Catharina-Ziekenhuis
Eindhoven, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Universitair Medisch Centrum Sint Radboud
Nijmegen, Netherlands
...and 4 more locations