Treatment-Naive EGFR-MutatedOligometastatic Non-Small Cell Lung Cancer
Conditions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The subjects must meet all the following inclusion criteria to be enrolled in this study: 1. Age over 18 years (inclusive). 2. Histologically or cytologically confirmed NSCLC. 3. <= 3 metastatic organs, with <= 5 metastatic lesions, and <= 3 lesions in a single organ, with non-regional lymph node metastasis, one lymphatic drainage area corresponding to one organ. The diagnosis of oligometastasis includes but is not limited to the following examinations: enhanced CT/MRI of the brain, enhanced CT of the chest and abdomen, bone scan (strongly recommended to perform enhanced CT/MRI + PET-CT). 4. According to the RECIST 1.1 standard, the subjects have at least 1 measurable target lesion and are suitable for precise repeated measurement. 5. Patients with postoperative recurrence of lung cancer or diagnosed with NSCLC after diagnosis, who have not received any systemic treatment, or have not progressed after 1 cycle of chemotherapy. 6. Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, either alone or with other site mutations coexisting) by testing. If the tumor tissue is accessible, it is recommended to send for tumor tissue examination; if the tumor tissue is inaccessible or the patient does not accept tissue biopsy, blood samples are sent for examination. 7. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2, and there has been no deterioration in the 2 weeks prior to enrollment, with a minimum expected survival of 12 weeks. 8. Pregnant women from the screening to the end of the study treatment should take appropriate contraceptive measures and should not breastfeed. Before administration of medication, the pregnancy test is negative, or one of the following standards proves that there is no pregnancy risk: a. Postmenopausal defined as age greater than 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy; b. Women younger than 50 years old, if amenorrhea occurs 12 months or more after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the laboratory reference range for postmenopause, can also be considered postmenopausal; c. Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but excluding bilateral tubal ligation. 9. Male patients from the screening to the end of the study treatment should use barrier contraception (i.e., condoms). 10. The subjects themselves voluntarily participate and sign the informed consent form in person.
Exclusion criteria
Exclusion criteria: If the subjects meet any of the following criteria, they will not be included in this study: 1. Patients have received any of the following treatments in the past: a. Have used any EGFR tyrosine kinase inhibitor (EGFR TKI) in the past; b. Have received any lung cancer radiotherapy in the past; c. Within 4 weeks before the first administration of the study drug, the patient has undergone major surgery (such as vascular access placement or CNS shunt surgery, except for biopsy-related surgeries), or has suffered from major traumatic injury; d. Within 3 weeks before the first administration of the study drug, the patient has used CYP3A4 inhibitors, inducers, or drugs with narrow therapeutic windows or herbal supplements that are CYP3A4-sensitive (Appendix E). 2. Patients with tumors that can be surgically removed. 3. Patients with symptomatic brain metastases. 4. Patients diagnosed with other malignant diseases within the past 2 years (excluding completely resected basal cell carcinoma, in situ bladder cancer, and cervical in situ cancer). 5. At the time of starting the study treatment, any unresolved toxicity of grade >= 2 caused by previous treatment (excluding alopecia and grade 2 platinum-related neuropathy) according to the CTCAE standard. 6. Patients with uncontrolled pleural effusion and/or pericardial effusion. 7. According to the investigator's judgment, there is evidence of severe or uncontrolled systemic diseases (such as severe mental, neurological disorders, epilepsy or dementia, unstable or un compensable respiratory, cardiovascular, liver or kidney diseases, left ventricular ejection fraction (LVEF) 2. 10. Have experienced myocardial infarction, coronary artery/peripheral artery bypass or cerebrovascular accident within 3 months. 11. Have any of the following cardiac examination results: a. The corrected QT interval (QTc) in the resting 12-lead electrocardiogram for men (QTc) > 450 msec, women > 470 msec, corrected by the Fridericia formula (QTcF); b. The resting ECG indicates various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, second-degree or above heart block, clinically significant ventricular arrhythmias or atrial fibrillation and PR interval > 250 msec); c. There are any factors that increase QTc prolongation or the risk of arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, long QT syndrome family history; d. Left ventricular ejection fraction (LVEF) <= 40%. 12. Have a history of severe interstitial lung disease, drug-induced interstitial lung disease, or a history of interstitial pneumonia requiring steroid treatment, or any evidence of clinical active interstitial lung disease. 13. Have insufficient bone marrow reserve or organ function, reaching the following laboratory limits: a. Absolute neutrophil count < 1.5 × 10^9 / L; b. Platelet count < 100 × 10^9 / L; c. Hemoglobin < 90 g/L ( < 9 g/dL); d. When there is no liver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Overall survival ; | — |
Countries
China
Contacts
Public ContactBingwen Zou
West China Hospital of Sichuan University
Outcome results
None listed