Completed Clinical Trials

Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)

By April 24, 2017 No Comments

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

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