Status:
TERMINATED
Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ce...
Detailed Description
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 adva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03460678
Start Date
February 28 2018
End Date
November 14 2018
Last Update
March 5 2020
Active Locations (2)
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1
King Hussein Cancer Center (KHCC)
Amman, Jordan, 11118
2
American University of Beirut Medical Center
Beirut, Lebanon, 1107 2020