randomized comparative study of erlotinib and pemetrexed in the maintenance treatment of advanced lung cancer patients.

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this multicenter randomized study is to compare the effectiveness and safety of erlotinib and pemetrexed in the maintenance treatment of patients with advanced non-squamous non-small cell lung cancer (nsclc)

a randomized multi-center prospective study to compare the 12-month effectiveness (survival) and safety of erlotinib and pemetrexed as maintenance treatment in two groups of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsclc) other than predominantly squamous cell histology, whose disease has not progressed immediately following platinum-based chemotherapy for 4 cycles administered per routine daily practice in each study center

Eligibility criteria:
inclusion criteria: * age ≥18 years * signed written informed consent * histologically or cytological diagnosed stage iiib/iv non-squamous histology nsclc * received platinum based doublet chemotherapy for 4 cycles as first line therapy before this study * patients upon enrolment has at least stable disease following the platinum doublet; with documented (confirmed or unconfirmed) radiographic evidence of a tumor response of complete response (cr), partial response (pr), or stable disease (sd) according to recist version 1.1 criteria * estimated life expectancy ≥ 3 months * eastern cooperative oncology group performance status (ecog ps) 0-2 * adequate organ function exclusion criteria: * age ˂18 years * predominantly squamous cell and/or mixed small cell, non-small cell histology * current treatment on another therapeutic clinical study or within the last 30 days of entering the study * spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease * any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack * ongoing cardiac dysrhythmias of national cancer institute-common terminology criteria for adverse events (nci ctcae) grade \>2, uncontrolled atrial fibrillation of any grade, or corrected qt interval (qtc) \>470 msec * pregnancy or breastfeeding * prior malignancy (other than current nsclc): patients will not be eligible if they have evidence of active malignancy (other than non-melanoma skin cancer or localized cervical cancer, or localized and presumed cured prostate cancer) within the last 3 years * other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impose, in the judgment of the investigator and/or sponsor, excessive risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate to enter this study * uncontrolled third-space fluid collections * progressive brain metastases * hypersensitivity to the study drugs * inability to take corticosteroid drugs, folic acid, or vitamin b12 * patients with epidermal growth factor receptor (egfr) positive, anaplastic lymphoma kinase (alk) positive (documented using fluorescence in situ hybridization (fish) and/or immunohistochemistry (ihc)), or unknown egfr and alk test results

Keywords: generic erlotinib generic pemetrexed nsclc non-squamous randomized study maintenance therapy tyrosine kinase inhibitor antifolate antineoplastic agents