Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Chinese PLA General Hospital Identifier:
First received: May 25, 2010
Last updated: May 26, 2010
Last verified: April 2010
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 .

Condition Intervention Phase
Neoplasms, Lung
Carcinoma, Non-Small Cell Lung
Drug Therapy
Genes, EGFR
Drug: Erlotinib
Drug: Docetaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival Analysis of A Chinese Randomized Crossover Study Comparing Erlotinib to Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Resource links provided by NLM:

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: three year ]

Secondary Outcome Measures:
  • progression-free survival during the first-line treatment [ Time Frame: 1 year ]
  • progression-free time during the second-line treatment [ Time Frame: 2 years ]
  • quality of life during the first-line therapy [ Time Frame: every 3 weeks during first-line therapy ]
  • quality of life during the second-line therapy [ Time Frame: every 3 weeks during the second-line therapy ]
  • response rates during the first-line treatment [ Time Frame: at 6 months from treatment initiation ]
  • response rates during the second-line treatment [ Time Frame: every 3 weeks during the treament, and and every 6 weeks thereafter ]
  • toxicity during the first-line treatment [ Time Frame: at 12 months from treatment initiation ]
  • toxicity during the second-line treatment [ Time Frame: end of study ]
  • preditive and prognostic markers for chemotherapy or erlotinib [ Time Frame: end of study ]
    tissues for markers analysis are acquired during diagnosis procedure with informed consent.

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: first-line erlotinib
erlotinib in first-line treatment and docetaxel/cisplatin in second-line treatment
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
Active Comparator: second-line erlotinib
docetaxel/cisplatin in first-line treatment and erlotinib in 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01131429

Contact: Liang-An Chen, MD, phD 86-10-66939361

China, Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Liang-An Chen, MD, phD    86-10-66939361   
Principal Investigator: Liang-An Chen, MD, phD         
Sponsors and Collaborators
Chinese PLA General Hospital
Study Chair: Liang-An Chen, M.D., Ph.D. Chinese PLA General Hospital, Beijing, China
  More Information

Responsible Party: Liang-An Chen, M.D., Ph.D, Chinese PLA General Hospital, Beijing, China Identifier: NCT01131429     History of Changes
Other Study ID Numbers: PLAGH-TKIs
Study First Received: May 25, 2010
Last Updated: May 26, 2010

Keywords provided by Chinese PLA General Hospital:
mutation analysis
targeted therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on April 28, 2017