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

NCT03460678 | Terminated Phase 4

• 1 other identifier: MRT-JOR-LEB-KSA-2016-04
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 2

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)

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Generic Erlotinib; Generic Pemetrexed; NSCLC; Non-squamous; Randomized Study; Maintenance Therapy; Tyrosine kinase inhibitor; Antifolate antineoplastic agents

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) in eligible patients randomized to erlotinib or pemetrexed treatment arms

  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)

  12 months

Secondary Outcomes (3)

• Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy

  12 months

• Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms

  12 months

• Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed

  12 months

Study Arms (2)

Pemetrexed Arm

OTHER

Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium)

Drug: Pemetrexed

Erlotinib Arm

OTHER

Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride)

Drug: Erlotinib

Interventions

Pemetrexed DRUG

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

Also known as: Pemitra®

Pemetrexed Arm

Erlotinib DRUG

Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) administered once daily until disease progression or unacceptable toxic effects

Also known as: Mirata®

Erlotinib Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead

Study Sites (2)

King Hussein Cancer Center (KHCC)

Amman, 11118, Jordan

Location

American University of Beirut Medical Center

Beirut, 1107 2020, Lebanon

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 9, 2018
• Study Start: February 28, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1); JO (1)