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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00589056
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer
* Locally advanced (stage III) disease
* Unresectable disease
* Candidate for concurrent definitive chemotherapy and thoracic radiotherapy, as determined by the treating physician
* No malignant pleural effusion
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin ≤ 1.5 mg/dL
* AST or ALT ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN
* FEV\_1 \> 600 cc
* Not pregnant or nursing
* Negative pregnancy test
* No weight loss \> 10% within the past 6 months
* No known HIV disease
PRIOR CONCURRENT THERAPY:
* No prior thoracic radiotherapy
* No prior HIV protease inhibitors
* More than 5 years since prior chemotherapy
* At least 3 weeks since prior exploratory thoracotomy
* No concurrent medications that would preclude nelfinavir administration, including any of the following:
* Amiodarone
* Quinidine
* Rifampin
* Dihydroergotamine
* Ergonovine
* Ergotamine
* Methylergonovine
* Hypericum perforatum (St. John's wort)
* Lovastatin
* Simvastatin
* Pimozide
* Midazolam
* Triazolam
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00589056
Study Brief:
Protocol Section:
NCT00589056