Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

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

Summary

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. 18~70 years

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

3. Presence of at least one index lesion measurable by CT scan or MRI

4. Ecog0-1

5. Expected life time longer than 12 weeks

6. 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)

7. Signed written informed consent

Exclusion Criteria:

• Patients have 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