Non-Small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DRUGSHR-1826
SHR-1826
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years 2. ECOG performance status score of 0 or 1; 3. Histopathologically confirmed advanced or metastatic non-small cell lung cancer; 4. Participants must provide archived or fresh tumor tissue; 5. Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease; 6. At least one measurable lesion according to RECIST v1.1 criteria; 7. Expected survival ≥3 months; 8. Adequate organ function;
Exclusion criteria
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms 2. History of or concurrent other malignancies; 3. Untreated spinal cord compression ; 4. Uncontrolled tumor-related pain; 5. Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1; 6. History of interstitial lung disease; 7. Severe cardiovascular/cerebrovascular diseases;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR assessed by IRC according to RECIST v1.1 s） | once every 6 weeks, estimated 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years |
| Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years |
| Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years |
| Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1; | Estimated 2 years |
| Overall Survival (OS). | Estimated 2 years |
Countries
China
Contacts
CONTACTYijun Jia
Outcome results
None listed