A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients

Inclusion Criteria:

• age over 18
• histologically or cytologically confirmted non-small cell lung cancer
• stage IIIb with pleural effusion or stage IV
• ECOG PS 0-2
• at least one measurable lesion
• expected life span more than 3 months
• normal bone marrow, liver, renal function
• no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
• more than 6 months from the last adjuvant chemotherapy

Exclusion Criteria:

• active infection
• severe comorbitidies
• pregnant or lactating women
• other invasive malignancies
• poorly controlled symptomatic brain metastases