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

Sponsor
Sun Yat-sen University
Study ID
NCT07630077
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan — DRUG
    4.8 mg/kg Intravenous injection until disease progression
  • ivonescimab — DRUG
    20 mg/kg Intravenous injection until disease progression

Study Details

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

Key Dates

First listed
Jun 5, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 2
    patients with HER2 amplification or overexpression who were diagnosed for the first time and had PD-L1 expression ≥ 1%
  • Experimental: cohort 1
    patients with HER2 amplification or overexpression who had failed first-line treatment

Primary Outcome Measure

Progression free survival [ Time Frame: assessed up to 36 months ]

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