SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC

Starting soon · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

This is a phase II, open-label, single-arm study evaluating the efficacy and safety of SHR-A1811 (a HER2-targeted ADC) combined with AK112 (a PD-1/VEGF bispecific antibody) in patients with HER2-amplified or overexpressed locally advanced or metastatic NSCLC.

Key facts

Study ID

NCT07489703

Run by

Sun Yat-sen University

People needed

30

Starts

2026-04-30

Expected to finish

2028-12-31

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed ICF.
• Age 18-75.
• ECOG PS 0-1.
• Life expectancy ≥3 months.
• Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.
• Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .
• ≥1 measurable lesion per RECIST 1.1.
• Adequate organ and bone marrow function.
• Use of effective contraception.

You may not qualify if…

• History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
• Arterial/venous thrombotic event within 6 months.
• Significant cardiovascular disease.
• Active autoimmune disease requiring systemic treatment.
• Use of systemic immunosuppressants within 2 weeks prior.
• Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
• Symptomatic, progressive, or diffusely spread CNS metastases.

Full record on ClinicalTrials.gov

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