CompletedPhase 3

Iressa as Second Line Therapy in Advanced NSCLC-Asia

South Korea163 participantsStarted 2005-09

Plain-language summary

This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma. * WHO Performance status 0-2 * NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy * Life expectancy of 12 weeks. Exclusion Criteria: * ALT/AST: \>2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver. * Inadequate bone marrow function; Absolute neutrophil count: \<1.5 x 109/L, Platelets: \< 100 x 109/L * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin or cervical cancer in situ

What they're measuring

Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors

Timeframe: Survival

Trial details

NCT IDNCT00478049

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-05

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