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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00723957
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma)
* Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy
* Available paraffin-embedded tissue to measure the expression levels of βIII tubulin
* Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field
* Karnofsky performance status of 70-100
* Life expectancy of at least 3 months
* Men and women, ages 18 years and older
Exclusion Criteria:
* Uncontrolled brain metastases
* Peripheral neuropathy greater than Grade 1
* Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery)
* Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix
* Known HIV-positive status
* Absolute neutrophil count lower than 1500 cells mm\^3
* Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome)
* Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN
* Serum creatine level of 1.5 mg/dL or higher
* Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation)
* Any prior antineoplastic systemic regimens.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00723957
Study Brief:
Protocol Section:
NCT00723957