Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Si-Yu Wang
• Treatments: Erlotinib Hydrochloride; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed Lung adenocarcinoma

• Wld-type EGFR

• Stage IIIB/IV

• Failure to prior chemotherapy

• Life expectancy of more than 3 months

• Tissue sample desired for genomic study

• Age ≥ 18 years

• Performance status (WHO) < 3

• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)

• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)

• Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated

• Informed consent

Exclusion Criteria:

• Have previously received pemetrexed or TKIs

• Other concurrent uncontrolled illness