SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities
Sponsor: Sun Yat-sen University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
PFS
Time frame: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
Secondary Endpoints
DOR
ORR
OS
Eligibility Criteria
Inclusion Criteria: 1. Signed ICF. 2. Age 18-75. 3. ECOG PS 0-1. 4. Life expectancy ≥3 months. 5. Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy. 6. Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression . 7. ≥1 measurable lesion per RECIST 1.1. 8. Adequate organ and bone marrow function. 9. Use of effective contraception. Exclusion Criteria: 1. History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis. 2. Arterial/venous thrombotic event within 6 months. 3. Significant cardiovascular disease. 4. Active autoimmune disease requiring systemic treatment. 5. Use of systemic immunosuppressants within 2 weeks prior. 6. Symptomatic pleural/pericardial/ascitic effusion requiring drainage. 7. Symptomatic, progressive, or diffusely spread CNS meta…
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Expert commentary on why this trial matters and what to watch for.
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