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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00661193
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Unspecified
* Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
* Selected stage IIIB disease (T4 \[secondary to malignant pleural effusion only\], any N, M0)
* Stage IV disease (any T, any N, M1 \[distant metastases present\])
* Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
* The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
* Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
* Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
* No untreated brain metastases
* Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
* Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration
PATIENT CHARACTERISTICS:
* Zubrod performance status 2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 1,000/mm³
* Serum bilirubin normal
* SGOT or SGPT normal
* Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
* Willing to provide prior smoking history as requested on the prestudy form
* No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
* No malabsorption syndrome or requirement for IV alimentation
* No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No significant history of cardiac disease, including any of the following:
* Uncontrolled high blood pressure
* Unstable angina
* Congestive heart failure
* Myocardial infarction within the past 6 months
* Cardiac ventricular arrhythmia requiring medication
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
* At least 1 year since prior adjuvant chemotherapy
* No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
* No prior EGFR inhibitors
* No prior surgical procedures affecting absorption
* No concurrent major surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00661193
Study Brief:
Protocol Section:
NCT00661193