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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00497250
Eligibility Criteria:
Inclusion Criteria:
* Understand and willing to sign the consent
* Provision of study-specific written informed consent
* Chinese ethnicity
* Histological or cytological conformation of NSCLC(maybe from initial diagnosis of NSCLC or subsequent biopsy). Of note,sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing and needle aspiration of a defined lesion are acceptable
* Stage IIIB or stage IV,excluding those with pericardial or uncontrolled (not stable in past 60 days) pleural effusion. Stage IV patients must either be symptomatic due to pulmonary malignancies or only have CNS or bone metastases if there is clinical evidence of stable disease (no steroid therapy or steroid dose being tapered) for ≥28 days.
* ≥ 1 prior chemotherapy regimen (at least one platinum-based) for treatment of their disease and will have been progressed or intolerant to their most recent prior chemotherapy
* FEV1≥ 1000cc (without bronchodilator)
* FEV1/FVC \>0.7 (with or without bronchodilator) or post-bronchodilator FEV1/FVC ≤0.7 but FEV1≥ 50% of predicted value
* 1 measurable lesion according to RECIST criteria
* Life expectancy of ≥24 weeks
* Zubord-ECOG criteria performance status0-2(Karnofsky\>60%)
* Normal organ and marrow function as defined below:
* Leukocytes≥3,000/µL
* Haemoglobin≥9g/dL (prior to transfusions)
* Absolute neutrophil count ≥1,500/µL
* Platelets ≥100,000/µL
* Total bilirubin\<1.5 X upper limit of normal
* AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
* Creatinine ≤ 2.5 mg/dl.
* Recovery from any acute toxicity related to prior therapy(CTC\<2)
Exclusion criteria:
* Prior iressa therapy or prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or Pan-HER family receptors or its associated tyrosine kinase
* Prior thoracic radiotherapy
* Prior palliative RT whose port involved the lung or mediastinum region
* Newly diagnosed CNS metastases that have not been treated with surgery and/or radiation
* Newly diagnosed painful bony metastases w/o cord compression yet not treated with surgery and/or radiation
* Evidence of visceral metastases
* \<21 days since prior chemotherapy, immunotherapy, or biological systemic anticancer therapy
* \<28 days since prior cranial and/or bone irradiation
* Unresolved chronic or late toxicity from previous anticancer therapy inappropriate for this study according to the investigator
* Allergic reactions attributed to compounds of similar chemical or biologic composition to iressa
* Other co-existing malignancies or malignancies diagnosed within the last 5 years except basal cell carcinoma or cervical cancer in situ
* Unable to ingest oral medications
* Any co-morbid pulmonary disease that may put the patient at risk of severe toxicities. Specially,
* Clinically active interstitial lung disease unless due to uncomplicated progressive lymphangitic carcinomatosis (except chronic stable radiographic changes who are asymptomatic)
* Severe chronic obstructive pulmonary disease (COPD) defined as post-bronchodilator FEV1/FVC ≤0.7 and FEV1 ≤ 50% of predicted value (American Thoracic Society (ATS) classification)
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St.John's Wort
* Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements
* Surgical incision from major surgery not healed
* Bleeding after biopsy(except small biopsy)
* Use a non-approved or investigational drug within 30 days before Day 1 of the trial treatment
* No measurable disease
* Pregnancy or lactating
* Receiving other investigational agents or devices
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00497250
Study Brief:
Protocol Section:
NCT00497250