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

NCT07669051 | Active Not Recruiting Phase 2

• 1 other identifier: SDZLEC2025-480-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

Ivonescimab; gradual progression; potential progression

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS was defined as the interval from diagnosis to disease progression or death from any cause.

  From randomization through to the end of study, planned duration was 20 months

Secondary Outcomes (1)

• OS

  From randomization through to the end of study, planned duration was 20 months

Study Arms (1)

Arm1

EXPERIMENTAL

All subjects will receive ivonescimab in combination with their original EGFR-TKI regimen.

Drug: ivonescimab plus EGFR-TKI.

Interventions

ivonescimab plus EGFR-TKI. DRUG

All subjects will receive ivonescimab in combination with their original EGFR-TKI regimen.

Arm1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
• Serum albumin (ALB) ≥ 28 g/L;
• 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;

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong cancer hospital and institute

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jinming Yu, Dr

  Shandong Cancer Hospital and Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 25, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)