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Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Phase 2
18 Years
70 Years
Open (Enrolling)
Toxicity, Non-small Cell Lung Cancer

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Trial Information

Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Inclusion Criteria:

- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small
cell lung cancer

- Age from 18 to 70 years old

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

- ECOG 0-1

- Expected life time longer than 12 weeks

- Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST
≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion Criteria:

- Patients have not used drugs according to protocol

- Patients were allergic to pemetrexed or cisplatin

- Patients received radiotherapy or other biological treatment 4 weeks before the trial

- Uncontrolled hydrothorax or hydropericardium

- neuropathy toxicity ≥ CTC 3

- Severe symptomatic heart disease

- Active upper gastrointestinal ulcer or digestive disfunction

- Severe infection or metabolic disfunction

- Patients with other malignant tumor

- Uncontrolled brain metastases

- Patients have accepted other clinical trials

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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:

Iressa combined with Pem/Cis



Start Date:

December 2009

Completion Date:

Related Keywords:

  • Toxicity
  • Non-Small Cell Lung Cancer
  • Objective response rate
  • Time to Progression
  • Quality of Live
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms