Description:
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)
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
MRT-JOR-LEB-KSA-2016-04
- NCT ID:
NCT03460678
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
Pemetrexed | Pemitra® | Pemetrexed Arm |
Erlotinib | Mirata® | Erlotinib Arm |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Pemetrexed Arm | Other | Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) | |
Erlotinib Arm | Other | Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Progression Free Survival is defined as the time from date of randomization to the date of tumor progression or death from any cause, assessed until at least 12 months after randomization.
Progression is defined using response evaluation criteria in solid tumors (RECIST version 1.1) |
Secondary Outcome Measures
Measure: | Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Overall survival time is defined as the time from date of randomization until the date of death from any cause, assessed until at least 12 months after randomization |
Measure: | Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Overall response defined using RECIST version 1.1 and the duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until at least 12 months after randomization as assessed every 6 weeks |
Measure: | Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Incidence rates, severity, relationship of adverse events (AEs) and serious AE (SAE) to treatment drugs, number of AEs leading to permanent treatment discontinuation and clinically relevant changes in laboratory tests will be recorded, estimated and presented |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Hikma Pharmaceuticals LLC |
Trial Keywords
- Generic Erlotinib
- Generic Pemetrexed
- NSCLC
- Non-squamous
- Randomized Study
- Maintenance Therapy
- Tyrosine kinase inhibitor
- Antifolate antineoplastic agents
Last Updated
March 5, 2020