Non-Small-Cell Lung Cancer
Conditions
Keywords
Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib
Brief summary
The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.
Interventions
DRUGgefitinib
Sponsors
Baohui Han
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Age \>=18 years 3. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) 4. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) 5. Measurable or non-measurable disease 6. Able to comply with study and follow-up procedures
Exclusion criteria
* Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology * Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer * Symptomatic or untreated brain metastases * Prior systemic chemotherapy for NSCLC * Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) * History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications * Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 6-month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 years | — |
| to evaluate the safety profile between three groups | 6 months | Toxicity will be graded according to NCI CTCAE, version 4.0. The analysis of safety/tolerability data will be descriptive; toxicity events will be individually tabulated. |
Countries
China
Outcome results
None listed