NCT01131429

A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Conditions

• Neoplasms, Lung
• Carcinoma, Non-Small Cell Lung
• Drug Therapy
• Genes, EGFR

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib 150 mg/d per os until proven disease progression
DRUG	Docetaxel	Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
DRUG	Cisplatin	cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
DRUG	Docetaxel	Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
DRUG	Cisplatin	Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
DRUG	Erlotinib	Erlotinib 150 mg/d per os as second-line treatment

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-06-01
• Completion: 2015-06-01
• First posted: 2010-05-27
• Last updated: 2010-05-27

Locations

1 site across 1 country: China