Non-small cell lung cancer
Conditions
Interventions
Trial Group:Subjects who met the inclusion criteria first received befotinib monotherapy. After 8 weeks (+/-7 days), peripheral blood was collected for ctDNA and TCR detection. Among them, patients wi
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be aged >= 18 years and = 12 weeks 7. Subjects must not have received prior systemic anti-tumor therapy for advanced NSCLC, including standard chemotherapy, biotherapy, targeted therapy, immunotherapy, or investigational drugs, before the start of study drug treatment. Patients who have received adjuvant therapy or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if no progression occurs within 6 months after treatment 8. Adequate organ function (1) Routine blood tests: (No blood transfusion, no use of G-CSF, no use of medication for correction within 14 days before screening) 1) HB >= 90 g/L 2) ANC >= 1.5 × 10^9/L 3) PLT >= 100 × 10^9/L 4) WBC >= 4.0 × 10^9/L and = 30 g/L 5) Cr = 60 mL/min (Cockcroft-Gault formula) 6) APTT <= 1.5 × ULN, and INR or PT <= 1.5 × ULN 9. Women of childbearing potential should agree to use contraception (e.g., intrauterine devices, contraceptives, or condoms) during the study and for 6 months after the study ends. A negative serum or urine pregnancy test within 7 days before enrollment is required, and they must not be breastfeeding. Male subjects should agree to use contraception during the study and for 6 months after the study ends 10. Voluntary participation in the study, signing the written informed consent form, good compliance, and providing blood samples
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer or NSCLC mixed with small cell lung cancer, neuroendocrine carcinoma, or other pathological types; 2. Confirmed EGFR exon 20 insertion mutations and non-classical mutations including L861Q, G719X, S768I; 3. Prior systemic anti-tumor therapy (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy) for advanced/metastatic NSCLC; 4. Symptomatic brain metastases, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease detected on imaging CT or MRI at screening (patients with brain metastases treated and clinically stable without progression for 4 weeks before enrollment may be included, provided no intracranial hemorrhage is confirmed by brain MRI, CT, or venography); 5. Known history of hypersensitivity to any active or inactive excipient of befotertinib, or drugs with similar chemical structure or class to befotertinib; 6. Presence of factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.; 7. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; 8. Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes mellitus, active bleeding, etc., or any active infection including untreated hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infection, as judged by the investigator to be unfavorable for study participation or protocol compliance; 9. QT prolongation >470 ms or any clinically significant cardiac arrhythmia; 10. Any other condition judged by the investigator to render the patient ineligible for this study, such as high likelihood of non-compliance with study procedures, restrictions, and requirements, or other circumstances at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Duration of Response (DoR);Disease Control Rate (DCR);Overall Survival (OS);12-month Progression-Free Survival Rate;24-month Progression-Free Survival Rate;12-month Overall Survival Rate;24-month Overall Survival Rate; | — |
Countries
China
Contacts
Public ContactZhou Zhiguo
The Fourth Hospital of Hebei Medical University
Outcome results
None listed