Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities

NCT07630077 | Not Yet Recruiting Phase 2

• 1 other identifier: B2025-730-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II trial in patients with locally advanced or metastatic non-small cell lung cancer harboring HER2 gene abnormalities （amplification or overexpression）with a performance status of 0 to1 who are planned to receive first-line treatment or who have falied the first-line treatment

Conditions

Non Small Cell Lung Cancer

Keywords

HER2 gene abnormalities (amplification or overexpression)

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  The time from the first treatment to disease progression or death due to any cause (whichever occurs first)

  assessed up to 36 months

Secondary Outcomes (4)

• Duration of Response

  up to 36 months

• Objective Response Rate

  up to 36 months

• Overall survival

  up to 60 months

• Incidence and severity of adverse events (AEs)

  through study completion, an average of 60 months

Study Arms (2)

cohort 2

EXPERIMENTAL

patients with HER2 amplification or overexpression who were diagnosed for the first time and had PD-L1 expression ≥ 1%

Drug: Trastuzumab Rezetecan; Drug: ivonescimab

cohort 1

EXPERIMENTAL

patients with HER2 amplification or overexpression who had failed first-line treatment

Drug: Trastuzumab Rezetecan; Drug: ivonescimab

Interventions

Trastuzumab Rezetecan DRUG

4.8 mg/kg Intravenous injection until disease progression

cohort 1; cohort 2

ivonescimab DRUG

20 mg/kg Intravenous injection until disease progression

cohort 1; cohort 2

Eligibility Criteria

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

You may qualify if:

• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count \> 90,000/mcL 19
• Hemoglobin ≥ 9 g/dL (allow for blood transfusion)
• Creatinine ≤ 1.5 × ULN
• Total bilirubin ≤ 1.5 mg/dL or ≤ 26 μmol/L
• If there is liver metastasis, AST (SGOT) / ALT (SGPT) ≤ 5 × ULN; if there is no liver metastasis, ≤ 2.5 × ULN
• Albumin ≥ 2.5 g/dL 9. Both the reproductive-aged women and their male partners must agree to take adequate contraceptive measures (hormonal or barrier methods; abstinence) before entering the study, during the study, and within 90 days after completing the study (hormonal or barrier methods; abstinence). If a woman becomes pregnant during the study or suspects she is pregnant, she should immediately inform the attending physician.
• Note: Reproductive-aged women are any women who meet the following criteria (regardless of sexual orientation, whether they have undergone tubal ligation or chosen to remain single):
• No hysterectomy or bilateral oophorectomy;
• No natural menopause for at least 12 consecutive months (i.e., any time during the previous 12 months there was menstruation).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, 510060, 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 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: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)