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A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Phase 2
18 Years
80 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

Inclusion Criteria:

- Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant
hydrothorax or hydropericardium) or IV non-small cell lung cancer

- ≥ 18 years old

- patients who have received more than one regimen of platinum-based chemotherapy;
patients who have received EGFR monoclonal treatment could also be enrolled

- At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and
can be measured by imaging tools

- have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks
from the last targeted therapy

- ECOG 0-2

- Expected life time longer than 3 months

- Normal laboratory values:

- leucocyte≥ 4×109/L

- neutrophil≥ 1.5×109/L

- platelet≥90×109/L

- Hemoglobin≥ 9g/L

- ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)

- serum creatinine<1.5 mg/dl

- bilirubin <1.5×ULN

- No allergy to biological drug

- Sign the consent forms

Exclusion Criteria:

- Patients who have previously received Docetaxel or anti-VEGF inhibitors

- Severe symptomatic heart disease

- Female patients during their pregnant and lactation period, or patients without

- Severe uncontrolled infection

- Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic
brain tumor

- Patients with other malignant tumor,except for basal cell carcinoma,squamous cell
carcinoma and carcinoma in situ

- Patients have accepted other clinical trials

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

six weeks

Safety Issue:


Principal Investigator

Jianhua Chang, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University affiliated cancer hospital


China: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Objective response rate
  • Disease control rate
  • Disease free survival
  • Overall survival
  • Quality of Live
  • Nonsmall cell lung cancer
  • toxicity
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms