A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis except for individuals who have previously treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or antiseizure
medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU