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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01282151
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 years old
* ECOG performance status 0-2
* Non-squamous cell type non-small cell lung cancer (NSCLC)
* Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
* No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
* No prior immunotherapy, biologic therapy
* Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Hemoglobin \>=9.0g/dl, Platelet \>=100,000/uL, neutrophil \>=1,500 /uL Creatinine \<=1.5 x upper normal limit or creatinine clearance \>=60 mL/min Bilirubin \<=1.5 x upper normal limit, Transaminases \<=2 x upper normal limit Alkaline phosphatase \<=2 x upper normal limit
* Written informed consent
Exclusion Criteria:
* Pregnancy, Lactating woman
* Woman in child bearing age who refuses to do pregnancy test
* Moderate or greater than grade 1 motor or sensory neurotoxicity
* Hypersensitivity to taxane
* Comorbidity or poor medical conditions
* Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
* Concurrent treatment with other investigational drugs within 30 days before randomization
* Active treatment with other anticancer chemotherapy
* EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01282151
Study Brief:
Protocol Section:
NCT01282151