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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT01951157
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed unresectable NSCLC
* Patients must have failed one prior line of CT-based therapy for unresectable disease
* Age between 18 and 75 years
* Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤ 1
* Adequate hematological, renal, metabolic and hepatic function
* At least three weeks since the last prior therapy, at least four weeks since completion of any prior radiotherapy
* Negative pregnancy test for pre-menopausal women
Exclusion Criteria:
* Concomitant diseases/conditions as unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50%, dyspnea, infection by human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active uncontrolled infection, pleural or pericardial effusions, myopathy, limitation of the patient's ability to comply with the treatment or to follow-up the protocol, any other major illness
* Histological features of neuroendocrine or bronchioalveolar differentiation.
* Unknown epidermal growth factor receptor (EGFR)mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
* Prior or concurrent invasive malignant disease, unless in complete remission for more than three years.
* Significant cancer-related weight loss (≥10%)within four weeks prior to treatment start
* Prior treatment with docetaxel-containing therapy
* Symptomatic, steroid-requiring or progressive central nervous system (CNS) involvement
* Paraneoplastic syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01951157
Study Brief:
Protocol Section:
NCT01951157