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Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

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ClinicalTrials.gov Identifier: NCT01024413
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : March 1, 2017
Guangdong General Hospital
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer

Brief Summary:
This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Condition or disease Intervention/treatment Phase
Thoracic Neoplasms Drug: erlotinib Drug: gefitinib Phase 3

Detailed Description:
Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations
Study Start Date : July 2009
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: erlotinib
erlotinib 150 mg oral till disease progression
Drug: erlotinib
study arm.erlotinib 150 mg oral till disease progression
Other Name: Tarceva
Active Comparator: gefitinib
gefitinib 250mg oral till disease progression.
Drug: gefitinib
study arm.gefitinib 250 mg oral till disease progression
Other Name: Iressa

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: two years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: three years ]
  2. Safety events [ Time Frame: two years ]
  3. Pharmacoeconomic [ Time Frame: two years ]
  4. Response rate [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB (wet) or IV NSCLC.
  • Patients with positive EGFR exon19 or exon21 mutation as confirmed by direct sequencing histologically.
  • Signing the informed consent form.
  • The vital organ functions are tolerant to therapy.
  • Have recovered to CTCAE2 grade below from toxicity of previous chemotherapy and radiotherapy
  • PS 0-2 scores.
  • Functional reserve of bone marrow is adequate, e.g. white blood cell count ≥3.0×109/L, planet count ≥90×109/L, and HB≥80×109/L.
  • Serum bilirubin is 2 times less than the upper limit of normal (ULN), ALT and AST are 3 times less than ULN; for liver metastases, ALT and AST need to be 5 times less than ULN; creatinine should be 2 times less than ULN.

Exclusion Criteria:

  • Informed consent is not provided.
  • Women of pregnancy or breastfeeding.
  • Have difficulty in swallowing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024413

China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Chinese Society of Lung Cancer
Guangdong General Hospital
Principal Investigator: Wu Yi Long, MD Guangdong General Hospital

Mok T, Wu Y-L, Thongprasert S, et al: Phase III, randomised, open-label, first-line study of gefitinib (G) vs carboplatin/paclitaxel (C/P) in clinically selected patients (PTS) with advanced non-small-cell lung cancer (NSCLC) (IPASS). Ann Oncol 19 (S8): viii1- viii4, 2008 (suppl 8)
Massuti B, Morán T, Porta R, et al: Multicenter prospective trial of customized erlotinib for advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Final results of the Spanish Lung Cancer Group (SLCG) trial. J Clin Oncol 27:15s, 2009 (suppl; abstr 8023)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yi-Long Wu, Professor, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT01024413     History of Changes
Other Study ID Numbers: C-TONG0901
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yi-Long Wu, Chinese Society of Lung Cancer:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Respiratory Tract Diseases
Lung Neoplasms
Epidermal growth factor receptor genes

Additional relevant MeSH terms:
Thoracic Neoplasms
Neoplasms by Site
Erlotinib Hydrochloride
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors