NCT02951637

Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

Detailed description

The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma. In addition, the overall survival and safety index will be collected for analyses.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Pemetrexed plus carboplatin combined with gefitinib	Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.
DRUG	Gefitinib	Gefitinib (250mg daily)

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-04-01
• Completion: 2019-12-01
• First posted: 2016-11-01
• Last updated: 2016-11-01