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 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT01038661
Eligibility Criteria:
Inclusion criteria:
* Histologic or cytologic diagnosis of advanced non-small-cell lung cancer (NSCLC)
* Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastasis (TNM) stage criteria of lung cancer, local advanced stage IIIB (not applicable for radical radiation therapy) disease or metastatic stage IV disease or recurrent disease
* At least one evaluable tumor lesion based on RECIST criteria (\>= 20 mm with conventional techniques or \>= 10 mm with spiral Computed Tomography scan)
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1
* Adequate bone marrow reserve
* absolute neutrophil count \>= 2.0×10\^9/L
* platelets \>= 100×10\^9/L
* hemoglobin \>= 9.0 g/dL
* Adequate hepatic function
* total bilirubin \<= Upper Normal Limit (UNL)
* Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) \<= 2.5 UNL
* alkaline phosphatase (ALP) \<= 5 UNL
* Adequate renal function (serum creatinine \<= UNL or creatinine clearance \>= 60 mL/min)
* No prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²)
* Prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery
* Childbearing potential either terminated or attenuated by the use of an approved contraceptive method
* Inform consent signed
Exclusion criteria:
* Other tumour type than advanced / metastatic NSCLC in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin).
* Presence of symptomatic central nervous system metastases
* Inadequate liver function
* total bilirubin \> 1 UNL
* ALT and/or AST\>1.5 UNL associated with alkaline phosphatase \> 2.5 UNL
* inadequate renal function (creatinine \> 1.0 times UNL and in case of limit value, creatinine clearance \< 60 mL/min)
* Prior radiation therapy, or surgery operation within 4 weeks
* Prior use of taxoids
* Active infection, or serious concomitant systemic disorder incompatible with the study
* Childbearing potential but unwilling to use of an approved contraceptive method
* Receive treatment from other clinical trials during this study treatment
* History of hypersensitivity to any of study medication
* Other serious concomitant abnormal or illness
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01038661
Study Brief:
Protocol Section:
NCT01038661