Condition
Metastatic Non-squamous Non Small Cell Lung Cancer
Estimated Enrollment: 201
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: CBP08-02
Study First Received: July 17, 2009
Last Updated: July 29, 2013
Estimated Primary Completion Date: July 2013
Primary Outcome Measures:
The primary efficacy endpoint is Progression free survival, analyzed in the treated population. PFS is assessed from randomization until either tumor progression, as per RECIST criteria, or until death due to any reason.|Objective response rate (CR + PR): response is to be assessed according to RECIST criteria (see Section 7.1), with responses to be confirmed at least 4 weeks after the first observation of response.|Duration of response is assessed in patients with confirmed response, from the first documentation of response until the first occurrence of disease progression. In case of death due to reasons other than disease progression, patie|Rate of tumor growth control (TGC): patients with tumor growth control are those patients who experience confirmed response (CR or PR) or stable disease lasting at least 12 weeks.|Duration of tumor growth control: duration of TGC is assessed from randomization to the first occurrence of disease progression or death in patients with confirmed TGC.|Overall survival: OS is assessed from randomization until the date of death from any cause.|Incidence and severity of adverse events and laboratory abnormalities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0|Occurrence of Serious Adverse Events.|Occurrence of treatment discontinuation due to adverse events.
Sponsors and Collaborators:
CanBas Co. Ltd.
Website Link: https://ClinicalTrials.gov/show/NCT00942825
