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Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: February 3, 2009
Last updated: September 19, 2012
Last verified: September 2012

This is an observational prospective study that investigates only daily practice. The prescription of anti-cancer medicine is separated from the decision to include the patient in this study. In addition, the assignment of the patient to a particular therapy or therapeutic strategy is not decided in advance by this study protocol, but falls within current practice.

The patient who fulfils eligible criteria will be enrolled when starts to receive the second-line EGFR-TKI therapy. The frequency of tumor response evaluation by RECIST criteria follows the investigator's discretion as daily practice.


Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparing Efficacy Between Anti-microtubule and Non-anti-microtubule as 3th Therapy After 2nd Line EGFR-TKI Therapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PFS of the third-line therapy [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • Overall objective tumor response (complete response [CR] + partial response [PR]) of the third-line therapy by RECIST criteria [ Time Frame: 9 months ]

Enrollment: 36
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The EGFR-TKI receiver who are suitable for third-line therapy will be followed up for the regimen of the third-line anti-microtubule agents or non-anti-microtubule agents

Inclusion Criteria:

  • At least one measurable lesion according to RECIST criteria
  • Histologically or cytologically confirmed NSCLC of adeno histology
  • Locally progressed or metastasized on or after first-line chemotherapy. The imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acce

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00836160

Research Site
Gueishan Township, Taiwan
Sponsors and Collaborators
  More Information

Responsible Party: AstraZeneca Identifier: NCT00836160     History of Changes
Other Study ID Numbers: NIS-OTW-DUM-2008/1
Study First Received: February 3, 2009
Last Updated: September 19, 2012

Keywords provided by AstraZeneca:
EGFR-TKI therapy
Efficacy processed this record on May 25, 2017