Clinical trial NCT03460678: Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.
Official title: Randomized Multicenter Study to Compare the Effectiveness and Safety of Erlotinib and Pemetrexed as Maintenance Therapy of Advanced Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Generic Erlotinib
Generic Pemetrexed
NSCLC
Non-squamous
Randomized Study
Maintenance Therapy
Tyrosine kinase inhibitor
Antifolate antineoplastic agents
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized into either the arm of Erlotinib 150 mg once daily, or the arm of Pemetrexed 500 mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects.
Primary purpose: TREATMENT

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 cell lung cancer (NSCLC)

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 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

Primary outcomes:
measure: Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms
timeFrame: 12 months
Secondary outcomes:
measure: Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy
timeFrame: 12 months
measure: Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms
timeFrame: 12 months
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center (KHCC)
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
References: