Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.

• Status: Terminated
• Trial end date: 2018-11-14
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hikma Pharmaceuticals LLC
• Treatments: Erlotinib Hydrochloride; Pemetrexed

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