Non-small cell lung cancer
Conditions
Interventions
Experimental group:Sequential furmonertinib after ablation or SABR
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in the clinical study; 2.Aged = 18 years at the time of signing the informed consent form; 3.Histologically or cytologically confirmed early-stage T1–3 N0 NSCLC, or patients with multiple primary lesions or solitary pulmonary parenchymal recurrence; 4.Confirmed presence of EGFR-sensitive mutations by genetic testing, including but not limited to Exon 19 deletion, L858R, G719X, L861Q, S768I, and their compound mutations; 5.ECOG performance status score of 0–2; 6.Deemed medically inoperable or refuse surgery after multidisciplinary evaluation; 7.Pulmonary lesions suitable for ablation or radiotherapy (either modality); 8.Adequate major organ function;
Exclusion criteria
Exclusion criteria: 1. Known severe allergic reaction (NCI-CTCAE v5.0 grade >= 3) to any monoclonal antibody or any excipient of the study drug; 2. Known contraindications to ablation or radiotherapy; 3. Failure to meet the minimum requirements for target coverage and dose constraints to organs at risk in the SABR treatment plan; 4. Active infection requiring systemic anti-infective therapy within 14 days prior to the first dose; 5. Any of the following within 6 months prior to the first dose: myocardial infarction; poorly controlled arrhythmias (including QTc interval >= 450 ms for males or >= 470 ms for females, calculated using Fridericia's formula); New York Heart Association (NYHA) class III–IV heart failure; left ventricular ejection fraction 1.5 mmol/L, calcium > 12 mg/dL, or corrected serum calcium > upper limit of normal); 7. Presence of severe interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function at baseline or during screening that, in the investigator's judgment, may interfere with the detection or management of suspected drug-related pulmonary toxicity; 8. Patients with hepatitis B (hepatitis B surface antigen [HBsAg] positive and detectable HBV-DNA indicating viral replication); hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV-RNA indicating viral replication); positive syphilis screening (except when specific antibody test is positive, non-specific antibody test is negative, and clinically confirmed as inactive infection); or known history of human immunodeficiency virus (HIV) infection or positive HIV screening; 9. Presence of other active malignancies within 5 years, or concurrent malignancies. Exceptions include localized tumors that have been cured for more than 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ; 10. Receipt of live or attenuated vaccines within 28 days prior to the first dose, or planned receipt of such vaccines during the study period. Inactivated seasonal influenza vaccines are permitted; 11. Receipt of curative-intent radiotherapy within 3 months prior to the first dose; 12. Spinal cord compression not definitively treated by surgery and/or radiotherapy; 13. Presence of deep vein thrombosis, current use of anticoagulant or antiplatelet therapy, or prior history of deep vein thrombosis or severe bleeding associated with antiangiogenic therapy; 14. Poorly controlled hypertension (defined as blood pressure >= 160/100 mmHg despite optimal antihypertensive therapy); 15. Major surgery within 28 days prior to the first dose (major surgery in this study is defined as any procedure requiring at least 3 weeks of recovery before the study treatment can be administered); 16. Concurrent participation in another clinical study, or receipt of intervention in any other clinical trial (including drugs and devices) within 3 months or 5 half-lives prior to screening, whichever is longer; 17. Planned or previous organ or bone marrow transplantation; 18. Known history of substance abuse or drug addiction; 19. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-year event-free survival rate;overall survival; | — |
Countries
China
Contacts
Public ContactXuefei Hu
Shanghai Pulmonary Hospital
Outcome results
None listed