NSCLC
Conditions
Brief 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.
Detailed description
Patients will be randomized to 2 groups
Interventions
DRUGSequential Gefitinib With Pemetrexed/Platinum
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 weeks of non-progression rate | from the first cycle of treatment (day one) to two month after the last cycle |
Secondary
| Measure | Time frame |
|---|---|
| PFS | from the first cycle of treatment (day one) to two month after the last cycle |
Countries
China
Outcome results
None listed