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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00862134
Eligibility Criteria:
Inclusion Criteria:
* Subjects with locally advanced or metastatic NSCLC (stage IIIb/IV) who have relapsed following adjuvant or first line therapy with a platinum containing regimen, and are appropriate candidates for treatment with single agent docetaxel
* Confirmed NSCLC by prior pathological analysis (tissue aspirate or biopsy)
* At least 21 days from prior chemotherapy
* At least 30 days from prior irradiation therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of 12 weeks or more
* Adequate hematologic function \[Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; platelet count ≥100x10\^9/L; hemoglobin ≥8.5 g /dL maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio ≤1.7; or prothrombin time ≤2 seconds above control)
* Adequate hepatic function (albumin ≥2.8 g/dL; total bilirubin ≤2 mg/dL \[51.3 μmol/L\]; and alanine aminotransferase and aspartate aminotransferase ≤1.5 times the upper limit of the normal range)
* Adequate renal function (serum creatinine ≤2.0 times the upper limit of the normal range or creatinine clearance ≥60 mL/min).
* At least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion Criteria:
* Previous treatment with docetaxel (prior treatment with paclitaxel permitted)
* Receipt of more than one prior systemic chemotherapy regimen
* Active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
* Women who are pregnant, breast-feeding or planning to become pregnant during the study
* Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose
* Evidence of a significant medical disorder or laboratory finding that, in the opinion of the Investigator, compromises the subject's safety during study participation
* Active Central Nervous System (CNS) metastatic disease requiring intervention
* Less than 4 weeks since major surgery
* Known human immunodeficiency virus (HIV) positivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00862134
Study Brief:
Protocol Section:
NCT00862134