A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
Open randomized multicenter phase II study in patiƫnts 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Imaging
Chest X ray, CT. Bone scan, brain scan (if clinically indicated) for Progression free survival Response rate Duration of response
Every 6 weeks until disease progression
No
Joachim G. Aerts, MD PhD
Study Director
Amphia Ziekenhuis, Breda, The Netherlands
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
NVALT10
NCT00835471
March 2009
June 2014
Name | Location |
---|