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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Carboplatin; Cisplatin; Gefitinib; Pemetrexed

Criteria

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 contraception