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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03460678
• Date of registration: 26/02/2018
• Prospective Registration: Yes
• Primary sponsor: Hikma Pharmaceuticals LLC
• Public title: Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.
• Scientific 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
• Date of first enrolment: February 28, 2018
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03460678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Jordan, Lebanon

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Pemetrexed

Drug: Erlotinib

Primary Outcome(s)

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

Secondary Outcome(s)

Overall response rate and duration between eligible patients randomized to erlotinib or pemetrexed treatment arms [Time Frame: 12 months]

Median Overall Survival (OS) Time between eligible patients randomized to erlotinib or pemetrexed treatment of therapy [Time Frame: 12 months]

Incidence of adverse events (AEs) and serious adverse events (SAEs) to erlotinib and pemetrexed [Time Frame: 12 months]

Secondary ID(s)

MRT-JOR-LEB-KSA-2016-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors