Clinical Trials /

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

NCT03460678

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)

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

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

DrugSynonymsArms
PemetrexedPemitra®Pemetrexed Arm
ErlotinibMirata®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

NameTypeDescriptionInterventions
Pemetrexed ArmOtherVials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium)
  • Pemetrexed
Erlotinib ArmOtherFilm coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride)
  • Erlotinib

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:Recruiting
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 15, 2018