NCT03460678

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

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

Timeline

• Start date: 2018-02-28
• Primary completion: 2018-11-14
• Completion: 2018-11-14
• First posted: 2018-03-09
• Last updated: 2020-03-05

Locations

2 sites across 2 countries: Jordan, Lebanon