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

• ClinicalTrials.gov Identifier: NCT03460678
• Recruitment Status: Terminated
• First Posted: March 9, 2018
• Last Update Posted: March 5, 2020
• Sponsor: Hikma Pharmaceuticals LLC
• Information provided by (Responsible Party): Hikma Pharmaceuticals LLC

Tracking Information

• First Submitted Date: February 26, 2018
• First Posted Date: March 9, 2018
• Last Update Posted Date: March 5, 2020
• Actual Study Start Date: February 28, 2018
• Actual Primary Completion Date: November 14, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2018)

Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms [ Time Frame: 12 months ]

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2018)

• Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy [ Time Frame: 12 months ]
  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
• Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms [ Time Frame: 12 months ]
  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
• Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed [ Time Frame: 12 months ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• Drug: Pemetrexed
  Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) administered as 500mg/m2 IV over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects
  Other Name: Pemitra®
• Drug: Erlotinib
  Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) administered once daily until disease progression or unacceptable toxic effects
  Other Name: Mirata®

Study Arms

• Pemetrexed Arm
  Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium)
  Intervention: Drug: Pemetrexed
• Erlotinib Arm
  Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride)
  Intervention: Drug: Erlotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 3, 2020): 9
• Original Estimated Enrollment (submitted: March 8, 2018): 72
• Actual Study Completion Date: November 14, 2018
• Actual Primary Completion Date: November 14, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Jordan, Lebanon

Administrative Information

• NCT Number: NCT03460678
• Other Study ID Numbers: MRT-JOR-LEB-KSA-2016-04
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hikma Pharmaceuticals LLC
• Study Sponsor: Hikma Pharmaceuticals LLC
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hikma Pharmaceuticals LLC
• Verification Date: March 2020