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

This study has been completed.
Guangdong General Hospital
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer Identifier:
First received: December 1, 2009
Last updated: September 30, 2015
Last verified: September 2015

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 Intervention Phase
Thoracic Neoplasms
Drug: erlotinib
Drug: gefitinib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase II/III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations

Resource links provided by NLM:

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

Primary Outcome Measures:
  • response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • progression-free survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: three years ] [ Designated as safety issue: No ]
  • Safety events [ Time Frame: two years ] [ Designated as safety issue: Yes ]
  • Pharmacoeconomic [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 256
Study Start Date: July 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Genders Eligible for Study:   Both
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.
  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: 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
  More Information

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)

Responsible Party: Yi-Long Wu, Professor, Chinese Society of Lung Cancer Identifier: NCT01024413     History of Changes
Other Study ID Numbers: C-TONG0901
Study First Received: December 1, 2009
Last Updated: September 30, 2015
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
Epidermal growth factor receptor genes

Additional relevant MeSH terms:
Thoracic Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on October 02, 2015