A Phase II Clinical Trial of Ivonescimab Plus Third-generation EGFR-TKIs in Advanced Non-small Cell Lung Cancer With Gradual or Potential Progression After EGFR-TKIs Treatment
ivonescimab plus EGFR-TKI.: All subjects will receive ivonescimab in combination with their original EGFR-TKI regimen.
Study summary
This is a prospective, single-center, Phase II clinical study designed to explore the efficacy and safety of ivonescimab plus third-generation EGFR-TKIs in patients with advanced EGFR-mutant non-small cell lung cancer who developed slow progression or potential progression after prior EGFR-TKI therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\. Voluntarily signed written informed consent form; 2. Age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Expected survival ≥ 3 months; 5. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC), which is unresectable for complete surgical resection and not eligible for radical concurrent/sequential chemoradiotherapy, staged per the 8th edition TNM Staging for Lung Cancer released by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC); 6. Positive EGFR sensitive activating mutation confirmed by tumor histology, cytology or hematology testing before enrollment, including exon 19 deletion (19Del) and exon 21 point mutation (L858R); patients with EGFR T790M mutation are also eligible for enrollment; 7. Developed slow progression or potential progression during EGFR-TKI therapy: 8. Presence of at least one measurable lesion; 9. Normal function of major organs, meeting all the following criteria:
Routine blood test results meet the requirements (no blood transfusion, no use of hematopoietic growth factors, no drug correction within 14 days before testing):
a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L (1,500/mm³); b. Platelet count (PLT) ≥ 90×10⁹/L (90,000/mm³); c. Hemoglobin (HB) ≥ 90 g/L; 10. Biochemical test results meet the following criteria:
1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
2. Serum albumin (ALB) ≥ 28 g/L;
3. Serum creatinine (sCr) ≤ 1.5×ULN; urine protein \< 2+ or 24-hour urinary total protein quantification \< 1.0 g (creatinine clearance calculated per Cockcroft-Gault formula); Coagulation function meets the requirements: International Normalized Ratio (INR) ≤ 1.5×ULN and activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
Exclusion Criteria:
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Primary outcome measure(s)
PFS — From randomization through to the end of study, planned duration was 20 months PFS was defined as the interval from diagnosis to disease progression or death from any cause.
Trial sites (1)
Facility
City
Region
Status
Shandong cancer hospital and institute
Jinan
Shandong
More Shandong Cancer Hospital and Institute trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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