NCT01665417

Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed description

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib. Primary endpoint: Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib Secondary endpoint: 1. Overall survival between icotinib and chemotherapy 2. Time to Progression between icotinib and chemotherapy 3. Objective response rate and disease control rate between icotinib and chemotherapy

Conditions

• EGFR Positive Non-small Cell Lung Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Experimental	Icotinib: 125mg, oral administration, three times per day.
DRUG	Chemotherapy	Chemotherapy Regimen 1：Pemetrexe 500 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
DRUG	Chemotherapy	Chemotherapy Regimen 2：Docetaxel 75 mg/m\^2 on Day 1, Cisplatin 75 mg/m\^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2012-08-15
• Last updated: 2017-02-08

Locations

1 site across 1 country: China