Clinical trial · Interventional
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
NCT07489703CI-TRIAL-00106329not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 plus AK112 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Cohort 1 includes patients who failed standard first-line therapy, patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.
- interventionNames
- Drug: SHR-A1811 plus AK112
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Cohort 2 includes treatment-naïve patients. Patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.
- interventionNames
- Drug: SHR-A1811 plus AK112
Primary outcomes (1)
- measure
- PFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 metastases.
References
Publications (0)
Data not yet available
No reference posted for this study.