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
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
90 participants
Apr 29, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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;
Exclusion Criteria7
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- History of or concurrent other malignancies;
- Untreated spinal cord compression ;
- Uncontrolled tumor-related pain;
- Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
- History of interstitial lung disease;
- Severe cardiovascular/cerebrovascular diseases;
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Interventions
SHR-1826
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07489716