A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer
Recruiting · NCT07489716 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
SHR-1826
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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;
Where it is running
1 location listed.
- Affiliated Cancer Hospital of Shandong First Medical University - Jinan, Shandong, China