Lung cancer
Conditions
Interventions
Metronomic Chemotherapy Combined with Third-Generation EGFR-TKI:1 Third-generation EGFR-TKI: Osimertinib (specification: 80mg/tablet, dosage: 80mg once daily)
or Aumolertinib (specification: 55mg/tablet, dosage: 110mg once daily)
or Furmonertinib (specification: 40mg/tablet, dosage: 80mg once daily) may be used.
2 Chemotherapy (Vinorelbine Capsules): Specification: 30-40mg/capsule
administration: 1 capsule, three times per week
one cycle is 28 days (4 weeks).
Sponsors
Beijing hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years; 2. ECOG performance status 0-2; 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIB, IIIC, or IV) NSCLC patients ineligible for radical concurrent chemoradiotherapy; 4. Tumor histology or cytology confirming EGFR-sensitive mutations (including exon 19 deletions and exon 21 L858R mutation); 5. No prior systemic antitumor therapy for locally advanced/metastatic disease (patients who received prior platinum-based adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease are eligible if disease progression occurred >6 months after completion of last treatment); 6. Life expectancy >= 3 months; 7. At least one measurable lesion confirmed by investigator per RECIST 1.1 criteria; 8. Normal major organ function with screening test results meeting: 1) Hematology (no transfusion/blood products or G-CSF/hematopoietic stimulators within 14 days): a.Hemoglobin >= 90g/L; b.ANC >= 1.5×10^?/L; c. Platelets >= 100×10^?/L. 2) Biochemistry: a. Liver function: Non-liver metastasis: total bilirubin 60mL/min (Cockcroft-Gault) ; c.Urinalysis: proteinuria(UPRO) <++ or 24-hour urinary protein <1g
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain metastases; 2. Known or suspected allergy to the investigational drug and/or its excipients. Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the investigational drug, or prior extensive bowel resection that may affect adequate absorption of the investigational drug; 3. History of malignancies other than NSCLC within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery; 4. Any unstable condition or medical status that, in the investigator's judgment, may compromise the participant's safety or study compliance, such as uncontrolled hypertension, uncontrolled diabetes, active bleeding tendency, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1year Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Disease control rate, DCR;?Treatment-Related Adverse Events?, TRAEs; | — |
Countries
China
Contacts
Public ContactNiexin
Beijing hospital
Outcome results
None listed