EGFR 20 exon insertion mutation in locally advanced or metastatic lung cancer
Conditions
Interventions
Experimental group:Oral BEBT-109
Sponsors
Hu'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is willing to sign the informed consent form after a comprehensive understanding; 2. Aged at least 18 years, no gender limit; 3. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM staging criteria for lung cancer: histologically or cytologically confirmed locally advanced (stage IIIB or IIIC, and not suitable for surgery or radiotherapy in the judgment of the investigator) or metastatic (stage IV) NSCLC; 4. NSCLC subjects who have failed at least one systemic chemotherapy (defined as after at least one platinum-based chemotherapy regimen or other chemotherapy regimens) or are intolerant to standard chemotherapy, and have previously confirmed EGFR 20 exon insertion mutation by written test report; 5. ECOG score of 0-2, and no decline in performance in the past two weeks, expected survival of at least 12 weeks; 6. The subject has at least one measurable lesion that meets the RECIST1.1 criteria; 7. Laboratory examination indicates that the subject has adequate organ function, including: (1) Neutrophil absolute value (ANC) >=1.5x10^9/L; Platelet count (PLT) >=100x10^9/L; Hemoglobin (HGB) >=80g/L; (2) Serum total bilirubin (TBIL) 1.5 ULN, the creatinine clearance rate should be checked for confirmation, and the creatinine clearance rate should be >=45ml/min (measured value or calculated value of Cockcroft-Gault formula); (4) Activated partial thromboplastin time (APTT) <=1.5 ULN, prothrombin time (PT) <=1.5 ULN, International Normalized Ratio (INR) <=1.5 ULN; 8. If female subjects of childbearing potential, adequate contraceptive measures (such as condoms, etc.) should be taken, breastfeeding should not be performed, and blood pregnancy test should be negative before administration; 9. Male subjects are willing to use barrier contraception, i.e., condoms, during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors within 5 years before enrollment, except resected and cured basal cell carcinoma, in situ bladder cancer or cervical carcinoma in situ; 2. Previous systemic anti-tumor therapy with third-generation EGFR TKIs (marketed drugs or drugs under development) or previous drugs targeting EGFR 20 exon insertion mutations (such as poziotinib, tarloxotinib, TAK788, JNJ-61186372, CLN-081, etc.); 3. Received any other anti-tumor therapy within 4 weeks before the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy or other biological therapy, mitomycin or nitrosamines within 6 weeks, small molecule targeted drugs at least 2 weeks away or at least 5 half-lives apart, whichever is longer); 4. Patients who have not withdrawn from other clinical trials within 4 weeks prior to the first dose of study treatment; 5. Major surgery (excluding vascular access) within 4 weeks before the first dose of study treatment; 6. Patients are currently taking or have taken drugs or herbal supplements known to be potent inhibitors or inducers of CYP3A4 and CYP2C8 within 1 week; 7. At the beginning of study treatment, there is still unhealed toxicity after previous treatment, and the Common Terminology Criteria for Adverse Events (CTCAE) grade is more than grade 1, but except alopecia, the neurological toxicity related to previous platinum therapy can be relaxed to grade 2; 8. Spinal cord compression, meningeal metastasis or brain metastasis, except asymptomatic, stable disease, no need for steroid treatment within 4 weeks before the start of study treatment; 9. Patients with obvious symptoms and unstable pleural effusion or abdominal effusion; patients with stable clinical symptoms for at least 28 days after pleural effusion or ascites treatment; 10. Patients with severe or uncontrolled systemic diseases requiring treatment, and the researchers believe that they are not suitable for participating in the trial, including hypertension, diabetes, chronic heart failure (NYHA functional classification III-IV), unstable angina pectoris, myocardial infarction within 1 year, active bleeding and other diseases; 11. Have uncontrolled active infection; 12. Clinically significant active infection including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number greater than the upper limit of normal of the laboratory department of the study site. Patients with HBV DNA copy number greater than the upper limit of normal of the clinical laboratory of the study site are allowed to be treated with antiviral drugs before screening, and only when the virus copy is reduced below the upper limit of normal, but patients need to receive continuous anti-hepatitis B virus treatment during the trial; active hepatitis C is defined as HCV RNA higher than the upper limit of detection; 13. History of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test, or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation; 14. At rest, the mean corrected QT interval (QTc) from 3 electrocardiograms (ECGs) was > 450 msec (the first ECG indicated QTc > 450 msec only required retesting 2 times, and the mean corrected value was taken 3 times); 15. A variety of serious and clinically significant abnormal heart rhythm, conduction, resting ECG morphology, such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Progression-free Survival;Disease Control Rate;Overall Survival;Safety;Time to React; | — |
Countries
China
Contacts
Public ContactQian Changgeng
BeBetter Med Inc.
Outcome results
None listed