Locally advanced or metastatic non-small cell lung cancer with EGFR 20 exon insertion mutations
Conditions
Interventions
Queue 1:Administer orally at a dose of 120 mg twice daily for 28 days (4 weeks).
Queue 2:Administer orally at a dose of 120 mg twice daily for 28 days (4 weeks).
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects were fully informed and willing to sign an informed consent form; 2. Be at least 18 years of age, regardless of gender; 3. Lung Cancer TNM Staging Criteria according to the American Joint Committee on Cancer (AJCC) 8th Edition: Histologically or cytologically diagnosed locally advanced (Stage IIIB or IIIC, and in the judgment of the investigator, not amenable to surgery or radiotherapy) or metastatic (Stage IV) NSCLC; 4. NSCLC patients who have failed at least one systemic chemotherapy regimen (defined as at least one platinum-containing chemotherapy regimen or other chemotherapy regimen) or who are intolerant to standard chemotherapy, and who have a documented history of an EGFR exon 20 insertion mutation; 5. ECOG score of 0-2 with no loss of fitness in the last 2 weeks and expected survival of at least 12 weeks; 6. The subject has at least 1 measurable lesion that meets the criteria of RECIST 1.1. 7. Laboratory tests suggesting adequate organ function, including: (1). Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L; platelet count (PLT) >= 100 x 10^9 /L; hemoglobin (HGB) >= 80g /L; (2). Serum total bilirubin (TBIL) 1.5 times ULN, creatinine clearance needs to be checked for confirmation, and creatinine clearance should be >=45 ml/min (measured value, or Cockcroft-Gault formula calculation); (4). Activated partial thromboplastin time (APTT) <=1.5 times ULN, prothrombin time (PT) <=1.5 times ULN, international normalized ratio (INR) <=1.5 times ULN; 8. In the case of female subjects of childbearing potential, adequate contraception (e.g., condoms) should be used, no breastfeeding should be allowed, and a negative blood pregnancy test should be performed prior to administration; 9. Male subjects were willing to use barrier contraception, i.e. condoms, for the duration of the study; 10.The written detection report confirms the occurrence of EGFR20 exon insertion mutation.
Exclusion criteria
Exclusion criteria: 1. Those who have suffered from other malignant tumors within 5 years prior to enrollment, except resected and cured basal cell carcinoma, bladder cancer in situ, or cervical cancer in situ; 2. Previous systemic antitumor therapy with a third-generation EGFR TKI (marketed or investigational) or a drug targeting an exon 20 insertion mutation in EGFR (e.g., Poziotinib, tarloxotinib, TAK788, JNJ-61186372, CLN-081, etc.); 3. have received any other antineoplastic therapy (including chemotherapy with cytotoxic agents, radiotherapy, immunotherapy, or other biological therapies within 4 weeks prior to the first dose of study drug, mitomycin or nitrosamines within 6 weeks, and small molecule-targeted agents within at least 2 weeks of the last dose or at least 5 half-lives, whichever is longer). 4. who received another clinical trial drug within 4 weeks prior to the first dose of study treatment; 5. Major surgery (excluding vascular access creation operations) within 4 weeks prior to the first dose of study treatment; 6. the subject is currently using or has used within 1 week a drug or herbal supplement known to be a potent inhibitor or inducer of CYP3A4 and CYP2C8; 7. Unresolved toxicity from prior therapy at the start of study treatment and CTCAE grade 1 or higher, except alopecia, which can be relaxed to grade 2 for neurologic toxicity associated with prior platinum-based therapy. 8. spinal cord compression, meningeal metastases, or brain metastases, except those who are asymptomatic, stable, and do not require treatment with steroids within 4 weeks prior to the start of study treatment; 9. Those with significant and unstable symptoms of pleural effusion or abdominal effusion; 10. have severe or uncontrolled systemic disease requiring treatment that, in the opinion of the investigator, makes them unsuitable for participation in the trial, including hypertension, diabetes mellitus, chronic heart failure (NYHA cardiac class III-IV), unstable angina pectoris, myocardial infarction within 1 year, active bleeding disorder, etc. 11. Persons with uncontrolled active infections; 12. The following clinically significant active infections, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as hepatitis B surface antigen (HBsAg) positivity with HBV DNA copies greater than the upper limit of normal in the laboratory of the investigational center; patients with HBV DNA copies greater than the upper limit of normal in the laboratory of the investigational center are permitted to be treated with antiviral medication prior to screening, and enrolled only if their viral copies are reduced to less than the upper limit of normal; however, patients will be required to continue to receive antiviral therapy for the duration of the trial; active hepatitis C is defined as HCV RNA; and active hepatitis C is defined as HCV RNA. Patients will be allowed to enroll until their viral copies are reduced to below the upper limit of normal, but will be required to remain on anti-hepatitis B virus therapy for the duration of the trial; 13. A history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 14. Mean corrected QT interval (QTc) >450 msec from 3 electrocardiograms (ECGs) at rest (2 retests are required for a first ECG suggesting QTc >450 msec, and the mean of the 3 corrections is taken); 15. Various serious a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Time to Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactHaiyan Tu
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed