Locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
Experimental group:Three generations of EGFR TKI
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the clinical study and sign the written informed consent. 2. Age between 18 and 75, male and female. 3. Patients with locally advanced or metastatic nonsquamous NSCLC (stage IIIB, IIIC, IV) who are histologically or cytologically inoperable and cannot receive radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer, TNM Stage 8. 4. Patients with classical mutations in previous EGFR gene tests and receiving first-generation or second-generation EGFR TKI, with one of the following conditions: (1) slow progression (the sum of the length and diameter of the target lesion increased from baseline = 3 months; 8. ECOG status score is 0-1 points; 9. The level of organ function must meet the following requirements: (1) Hematological indicators: neutrophils absolute count >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 90 g/L; (2) Liver function: total bilirubin = 60ml/min; (4) Coagulation function: INR, PT and APTT <= 1.5 times the upper limit of normal value; (5) The ECG is basically normal. 10. Female subjects of childbearing age must have a serum pregnancy test with negative results within 3 days prior to the first dosing and are not lactating. If they have had sex with an unsterilized male partner, they must use an acceptable and effective contraceptive method within 120 days from the start of screening until the last dosing;Unsterilized male subjects who have sex with a female partner of reproductive age must use an acceptable and effective contraceptive method within 120 days from the start of screening until the last dose.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study: 1. Subjects had cancerous meningitis. 2. Subject with active central nervous system (CNS) metastases should be excluded.Subjects may participate in the study if their CNS metastasis is adequately treated and if their neurological symptoms return to baseline at least 2 weeks prior to enrollment (except for residual signs or symptoms associated with CNS treatment).In addition, subjects must either be non-corticosteroid subjects or receive a steady or gradually reduced dose of prednisone (or equivalent) =10mg/ day. 3. Subjects with active, known or suspected autoimmune diseases were excluded.Subjects with type 1 diabetes, hypothyroidism that requires hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recuperate in the absence of an external trigger are eligible for inclusion. 4. Have coagulation dysfunction or bleeding tendency, or have a history of thrombus or hemorrhagic disease; 5. Those receiving anticoagulant or thrombolytic therapy; 6. The presence of unhealed wound ulcers or fractures; 7. Positive hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCAB), indicating acute or chronic infection. 8. According to chest X-ray examination, sputum examination and clinical physical examination, active tuberculosis (TB) infection is determined.Patients with a history of active tuberculosis infection within the previous 1 year, even if they have been treated, should also be excluded.Patients with a history of active TB infection more than 1 year ago should also be excluded unless the course and type of anti-TB treatment previously used is demonstrated to be appropriate. 9. Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension. 10. Known allergies to any of the study drugs or their exciphers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactZhong Lin
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed