Clinical trial · Interventional
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
NCT07669051CI-TRIAL-00115931active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ivonescimab plus EGFR-TKI. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm1
- description
- All subjects will receive ivonescimab in combination with their original EGFR-TKI regimen.
- interventionNames
- Drug: ivonescimab plus EGFR-TKI.
Primary outcomes (1)
- measure
- PFS
- timeFrame
- From randomization through to the end of study, planned duration was 20 months
- description
- PFS was defined as the interval from diagnosis to disease progression or death from any cause.
Secondary outcomes (1)
- measure
- OS
- timeFrame
- From randomization through to the end of study, planned duration was 20 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available
No reference posted for this study.