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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT03153358
Eligibility Criteria:
Inclusion Criteria:
* Histologic documentation of primary lung carcinoma, non-squamous histology with EGFR mutation.
* Stage disease according to the 7th Edition of the American Joint Committee on Cancer staging system
* Not received radiotherapy, chemotherapy or other biological treatment
* Measureable disease
* Life expectancy of\>=12 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Absolute neutrophil count (ANC)\>=2,500/mm\^3
* Hemoglobin\>=9.0 g/dL
* Total bilirubin\<=1.5 x upper limit of normal(ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine transferase \[ALT\])\<=2.5 x ULN in patients without liver or bone metastases; \<5 x ULN in patients with liver or bone metastases
* Cockcroft-Gault calculated creatinine clearance of\>=45 ml/min or creatinine\<=1.5 x ULN
* Prothrombin time (PT)\<=1.5 x ULN
* Partial thromboplastin time (PTT)\<=ULN
* Negative pregnancy test done\<=7 days prior to randomization, for women of childbearing potential only
* Provide informed written consent
* Willing to return to Sichuan cancer hospital for follow-up
* Willing to provide tissue and blood samples for correlative research purposes
Exclusion Criteria:
* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Known allergic to EGFR TKI any ingredients
* Prior chemotherapy or treatment for metastatic non-small cell lung cancer
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per MD discretion
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy\<=3 years prior to randomization;
* Ongoing or active infection, symptomatic congestive heart failure , cardiac arrhythmia, psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
* History of bleeding diathesis or coagulopathy
* Inadequately controlled hypertension (systolic blood pressure of\>150 mmHg or diastolic pressure\>100 mmHg on anti-hypertensive medications)
* Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury \<=28 days or core biopsy \<=7 days prior to randomization
* Pregnancy or breast-feeding women
* Other situation which researchers think that doesn't fit into the group
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03153358
Study Brief:
Protocol Section:
NCT03153358