NCT07896005Not yet recruitingPhase 3
A Study of SHR-A1811 Combined With Adebrelimab for the First-line HER2-overexpressing Non-squamous Non-small Cell Lung Cancer
A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is a randomized, open-label, multicenter, phase 3 clinical study comparing the efficacy and safety of SHR-A1811 in combination with Adebrelimab versus platinum-based doublet chemotherapy in combination with Tislelizumab as first-line treatment in patients with HER2-overexpressing locally advanced or metastatic non-squamous non-small cell lung cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 436 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 28 Feb 2031
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07896005
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 436
- From 1 Dec 2026 to the primary completion date, 28 Feb 2031
- 2 sites in 1 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
- Previous or current with other malignancies.
- Prior antitumor toxicity and/or complications have not recovered to NCI-CTCAE ≤ Grade 1.
- Currently participating in another clinical study, or the interval between the start of study treatment and the end of the previous clinical study is less than specified period.
- Participants with active or previous autoimmune diseases.
Other illness
- Participants with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- Participants with uncontrolled or severe cardiovascular diseases.
- Participants with active hepatitis B or hepatitis C.
Who the study is looking for
- Able to provide informed consent, willing and able to comply with the scheduled visits, examinations, and other procedural requirements of the treatment.
- Aged 18-75 years (inclusive) at the time of signing the informed consent form, with no restriction on sex.
- ECOG score of 0 or 1.
- Patients with histologically confirmed locally advanced or metastatic non-squamous NSCLC.
- Participants with HER2 overexpression confirmed by a central laboratory.
- Have not previously received systemic antitumor therapy for locally advanced or metastatic NSCLC.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.