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

This study has been completed.
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: August 4, 2014
Last verified: August 2014
  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
Drug: 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 ]

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

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

Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
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: August 4, 2014
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:
Carcinoma, Non-Small-Cell Lung
Neoplasms
Thoracic Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Erlotinib
Gefitinib
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014