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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT00707304
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed stage IIIB or IV NSCLC
* Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC
* At least one target lesion that is unirradiated and measurable by RECIST
* Adequate hematologic, renal and hepatic function
* ECOG 0, 1, or 2
* Able to understand and sign an Informed Consent
Exclusion Criteria:
* Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization
* Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications
* History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years
* Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
* Serious active infection
* Psychiatric illness/ social situations that would limit study compliance
* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
* Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
* Known HIV positive or on active anti-retroviral therapy
* Known Hepatitis B surface antigen positive or hepatitis C positive
* Receipt of any investigational medication within 4 weeks prior to randomization
* Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
* Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment
* Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00707304
Study Brief:
Protocol Section:
NCT00707304