Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01404260
Eligibility Criteria:
Inclusion Criteria:
* After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable disease(SD) by RECIST1.1.
* Patients between 18 and 75 years of age.
* Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
* No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
* Never smokers(defined as having smoked less than 100 cigarettes in their lifetime ) or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1 of study treatment and having smoked 10 pack-years or fewer).
* EGFR mutation status unknown.
* ECOG performance status of 0 or 1.
* Adequate organ function.
* Prior radiation therapy allowed to \<25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
* Signed informed consent document on file.
* Estimated life expectancy of ≥12 weeks.
* Patient compliance and geographic proximity that allow adequate follow up.
Exclusion Criteria:
* Known severe hypersensitivity to gefitinib.
* Sympotomatic patients with brain metastases.
* Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Interstitial pneumonia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01404260
Study Brief:
Protocol Section:
NCT01404260