NCT07489703Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 30 Apr 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT07489703
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 30 Apr 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic immunosuppressants within 2 weeks prior.
Other illness
- History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
- Significant cardiovascular disease.
- Active autoimmune disease requiring systemic treatment.
Other
- Arterial/venous thrombotic event within 6 months.
- Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
- Symptomatic, progressive, or diffusely spread CNS metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.