Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation:A Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Chinese Society of Lung Cancer
Sponsor:
Collaborator:
Guangdong General Hospital
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT01024413
First received: December 1, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

This is a randomized open-label controlled phase II trial comparing efficacy of erlotinib and gefitinib in patients with exon21 mutation advanced NSCLC as a first line treatment setting.


Condition Intervention Phase
Thoracic Neoplasms
Drug: erlotinib,gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation

Resource links provided by NLM:


Further study details as provided by Chinese Society of Lung Cancer:

Primary Outcome Measures:
  • response rate [ Time Frame: 2011-07 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progress free survival [ Time Frame: 2011-07 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: erlotinib, EGFR TKI, Tablet
study arm. erlotinib 150 mg oral till disease progression.
Drug: erlotinib,gefitinib
The patients will be randomized to received erlotinib or gefitinib.
Other Name: Tarceva
Active Comparator: gefitinib, EGFR TKI, Tablet
gefitinib 250mg oral till disease progression.
Drug: erlotinib,gefitinib
The patients will be randomized to received erlotinib or gefitinib.
Other Name: Tarceva

Detailed Description:

Patients with stage IV NSCLC who have exon21 mutation will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological documented stage IV or wet IIIB NSCLC.
  • No systemic antic cancer treatment or PD after first or second line chemotherapy.
  • Gene analyses of tumor tissue confirmed exon21 EGFR mutation.
  • Signed inform consent.
  • Enough vital organ function.
  • Patient has recovered from CTCAE grade 3/4 toxicity.
  • ECOG Performance Status 0, 1 or 2.
  • Haemoglobin>10.0 g/dl, Absolute neutrophil count (ANC) >1.5 x 109/L,platelets100 x 109/L.
  • Total bilirubin<1.5 x upper limit of normal (ULN),ALT and AST<2.5 x ULN in the absence of liver metastases, or<5 x ULN in case of liver metastases.

Creatinine clearance < 2.0 x ULN .

Exclusion Criteria:

  • Fail to acquire the inform consent.
  • Pregnant or breast-feeding women.
  • Unable to swallow the drug.
  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 ClinicalTrials.gov identifier: NCT01024413

Contacts
Contact: Wu Yi Long, MD 862083827812 ext 21187 syylwu@live.cn
Contact: Huang Yu Juan, MD 862083827812 ext 50810 w.hyj@163.com

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wu Yi-Long, MD    862083827812 ext 21187    syylwu@live.cn   
Contact: Yang Jin-Ji, MD    862083827812 ext 50810    yangjinji2003@163.com   
Principal Investigator: Wu Yi Long, MD         
Sponsors and Collaborators
Chinese Society of Lung Cancer
Guangdong General Hospital
Investigators
Principal Investigator: Wu Yi Long, MD Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Yi-Long Wu, Professor, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT01024413     History of Changes
Other Study ID Numbers: C-TONG0901
Study First Received: December 1, 2009
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Chinese Society of Lung Cancer:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Respiratory Tract Diseases
Lung Neoplasms
Erlotinib
Gefitinib
Epidermal growth factor receptor genes

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Thoracic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Erlotinib
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014