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Phase Ⅱ Study of Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation

Phase 2
Open (Enrolling)
Thoracic Neoplasms

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Trial Information

Phase Ⅱ Study of Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:


Safety Issue:


Principal Investigator

Wu Yi Long, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Thoracic Neoplasms
  • Thoracic Neoplasms
  • Molecular Mechanisms of Pharmacological Action
  • Protein Kinase Inhibitors
  • Respiratory Tract Diseases
  • Lung Neoplasms
  • Erlotinib
  • Gefitinib
  • Epidermal growth factor receptor genes
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Thoracic Neoplasms