NCT07489716RecruitingPhase 2
A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer
A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 29 Apr 2026
- Primary completion date
- Aug 2028
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07489716
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 29 Apr 2026 to the primary completion date, Aug 2028
- 1 site 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
- History of or concurrent other malignancies;
- Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
Other illness
- History of interstitial lung disease;
- Severe cardiovascular/cerebrovascular diseases;
Other
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Untreated spinal cord compression ;
- Uncontrolled tumor-related pain;
Who the study is looking for
- Aged 18-75 years
- ECOG performance status score of 0 or 1;
- Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
- Participants must provide archived or fresh tumor tissue;
- Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
- At least one measurable lesion according to RECIST v1.1 criteria;
- Expected survival ≥3 months;
- Adequate organ function;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.