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A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients


Phase 4
19 Years
80 Years
Not Enrolling
Both
Non Small Cell Lung Carcinoma

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Trial Information

A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients


Inclusion Criteria:



- Pathological Diagnosis of local advanced/metastatic Non Small Cell Lung Carcinoma

- Previously failed the first-line chemotherapy

- Patient who can provide sample for EGFR mutation test

Exclusion Criteria:

- Central Nervous System metastasis or spinal cord compression that has not yet been
definitively treated with surgery and/or radiation

- Any evidence of clinically active interstitial lung disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate(ORR)

Outcome Description:

Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated. According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Outcome Time Frame:

Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

D7913L00067

NCT ID:

NCT00608868

Start Date:

January 2007

Completion Date:

January 2009

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Carcinoma
  • Non Small Cell Lung
  • EGFR mutation
  • Gefitinib
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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