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

UNKNOWNPHASE2

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

NCT01131429•Chinese PLA General Hospital

View on ClinicalTrials.gov

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 .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients aged over 18 years
•Histologically proven lung adenocarcinoma
•clinical stage IIIB/IV
•ECOG performance status 0-2
•Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
•At least one measurable lesion (according to RECIST)
•Provision of written informed consent
•Life expectancy of at least 12 weeks

Exclusion Criteria

•History of malignant disease.
•Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
•Expected life expectancy less than 2 months
•As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
•Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or \>5 x in presence of liver metastases)
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
•Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 1, 2010

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2015

Last Updated

May 27, 2010

Enrollment

ESTIMATED participants

Conditions

Neoplasms, LungCarcinoma, Non-Small Cell LungDrug TherapyGenes, EGFR

Interventions

Erlotinib

DRUG

Docetaxel

DRUG

Cisplatin

DRUG

Docetaxel

DRUG

Cisplatin

DRUG

Erlotinib

DRUG

Contacts

Liang-An Chen, MD, phD

CONTACT

86-10-66939361 chenla301@263.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 27, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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