2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00835471|
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: erlotinib plus docetaxel or pemetrexed Drug: erlotinib||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2019|
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
Drug: erlotinib plus docetaxel or pemetrexed
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.
Active Comparator: 2
erlotinib 150 mg/day continuously until disease progression
Other Name: Tarceva
- Progression Free Survival (PFS) [ Time Frame: From randomisation to date of first progression or date of death, assessed up to 36 months ]to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
- Number of Adverse Events [ Time Frame: From randomisation to 30 days after EoT all AEs are collected ]to compare relevant toxicity (CTC AE vs 3.0) in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835471
|VU medisch centrum|
|Rode Kruis Ziekenhuis|
|Reinier de Graaf Gasthuis|
|Jeroen Bosch Ziekenhuis|
|Den Bosch, Netherlands|
|Academisch Ziekenhuis Maastricht|
|Universitair Medisch Centrum Sint Radboud|
|Sint Franciscus Gasthuis|
|The Hague, Netherlands|
|Study Director:||Joachim G. Aerts, MD PhD||Amphia Ziekenhuis, Breda, The Netherlands|
|Study Director:||Henk E. Coderington, MD||HagaZiekenhuis, The Hague, The Netherlands|