non-small cell lung cancer (NSCLC)
Conditions
Interventions
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit. 2. The Eastern Tumor Consortium (ECOG) had a physical status score of 0 or 1, did not worsen for at least 2 weeks prior to study drug therapy, and expected survival was not less than 12 weeks. 3. Histologically or cytologically confirmed locally advanced or metastatic stage IIIB-IV NSCLC (including patients with recurrent or newly diagnosed advanced NSCLC after prior surgical treatment; According to AJCC 8th Edition of lung cancer staging criteria). 4. No systemic treatment was received after diagnosis of stage IIIB-IV NSCLC. Patients who have received local treatment may participate in the study if the lesions within the local treatment range are non-target lesions. 5. A tumor tissue sample or blood sample was confirmed as an EGFR-sensitive mutation (21 L858R) by an investigator-approved local laboratory test. 6. Asymptomatic patients with brain metastases can be enrolled. 7. Women of childbearing age should take appropriate contraceptive measures and should not breastfeed for 3 months from screening to cessation of study treatment.
Exclusion criteria
Exclusion criteria: 1. Received any of the following treatments: (1) Previous use of any EGFR tyrosine kinase inhibitor; (2) Subjects underwent major surgery (e.g., craniotomy, thoracotomy, or laparotomy, as determined by the investigator) within 4 weeks prior to initial administration of the study drug; (3) Use of CYP3A4 booster, inducer or CYP substrate (CYP2C8, CYP2D6, etc.) within 7 days prior to initial administration of the study drug. 2. Complicated with other malignancies, except cutaneous basal cell carcinoma and carcinoma in situ. 3. At the beginning of the study treatment, there were unmitigable residual toxicity of previous treatment greater than grade 1 CTCAE, except for hair loss and grade 2 neurotoxicity caused by previous chemotherapy. 4. Severe gastrointestinal dysfunction that may affect drug intake, transport or absorption, such as inability to take drugs orally, uncontrollable nausea or vomiting, extensive gastrointestinal excision history, untreated recurrent diarrhea, atrophic gastritis, untreated stomach diseases requiring long-term use of proton pump inhibitors, Crohn's disease, ulcerative colitis, etc. 5. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis. 6. A history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease. 7. A history of hypersensitivity to any active or inactive component of amidinib or to drugs similar in chemical structure to amidinib or in the same class of amidinib. 8. Expected survival time is less than 3 months. 9. Patients with grade 2 or above hypertension before treatment and no improvement or instability after treatment with antihypertensive drugs; Patients with hypertensive crisis or hypertensive encephalopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactFeng Gang
Mianyang Central Hospital
Outcome results
None listed