Phase
Condition
Non-small Cell Lung Cancer
Cancer
Lung Disease
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients have voluntarily to join the study and give written informed consent for thestudy
Histologically documented, unresectable, inoperable, locally advanced, recurrent ormetastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
Mutation status including EGFR, ALK ROS are explicit;
At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria inSolid Tumours (RECIST) criteria.
Patients did not receive systemic anti-cancer therapy previously, includingtraditional Chinese medicine.
Able to comply with study and follow-up procedures
Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3months;enough organ function;
8)Major organ function
For regular test results(no blood transfusion within 14 days):
Hemoglobin(HB)≥90g/L;
Absolute neutrophils count(ANC)≥1.5×109/L;
Blood platelets(PLT)≥80×109/L
Biochemical tests results defined as follows:
Total bilirubin(TBIL)≤1.5 times the upper limit of normal (ULN) ;
Alanine aminotransferase(ALT)and aspartate aminotransgerase AST≤2.5ULN,livermetastases,if any,ALT和AST≤5ULN;
Creatinine(Cr)≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min;
Doppler ultrasound assessment:left ventricular ejection fraction (LVEF) ≥the lowerlimit of normal value(50%).
Exclusion
Exclusion Criteria:
Small cell lung cancer(including patients with mixed small cell lung cancer andnon-small cell lung cancer) or central squamous cell carcinoma with cavity
Mutation status are unknown
Previously (within 5 years) or presently suffering from other malignancies,
Symptomatic or uncontrolled brain metastases
Unstable systemic disease, including active infection, uncontrolled hypertension,unstable angina, congestive heart failure, or myocardial infarction within 6 months orserious cardiac arrhythmia requiring medication
History of other diseases, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or that might affect theinterpretation of the results of the study or render the patient at high risk fromtreatment complications
Gastrointestinal tract disease resulting in an inability to take oral medication or arequirement for intravenous (IV) alimentation, or prior surgical procedures affectingabsorption
Pregnancy or lactation
Previously treated including treated with traditional Chinese medicine
Patients who are allergic to any of the agent or any ingredient -
Study Design
Connect with a study center
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaActive - Recruiting

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