Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1826 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1826
- interventionNames
- Drug: SHR-1826
Primary outcomes (1)
- measure
- ORR assessed by IRC according to RECIST v1.1 s）
- timeFrame
- once every 6 weeks, estimated 2 years
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
- timeFrame
- once every 6 weeks, estimated 2 years
- measure
- Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available