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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00345059
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age \> 18
* Histological diagnosis of non small-cell lung cancer (NSCLC)
* Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)
* Disease in progression
* Previous chemotherapy with platinum-derivative (and with \> 21 days from last administration)
Exclusion Criteria:
* ECOG performance status \> 2
* Age \> 75 years
* History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Previous treatment with docetaxel
* Presence of symptomatic cerebral metastasis
* Neutrophils \< 2.0 x 109/l, platelets \< 100,000/l, hemoglobin \> 10g/dl
* Bilirubin \< 1.5 x the upper normal limit
* SGOT , SGPT, or bilirubin \> 1.25 x the upper normal limits except in the presence of hepatic metastasis
* Creatinine \>1.25 x the upper normal limit
* Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol
* Inability to comply with follow up
* Pregnant or nursing females
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00345059
Study Brief:
Protocol Section:
NCT00345059