A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1826.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug SHR-1826
SHR-1826
Primary outcome measures
- ORR assessed by IRC according to RECIST v1.1 s） [Time frame: once every 6 weeks, estimated 2 years]
Secondary outcome measures (5)
- Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1; [Time frame: once every 6 weeks, estimated 2 years]
- Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1; [Time frame: once every 6 weeks, estimated 2 years]
- Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1; [Time frame: once every 6 weeks, estimated 2 years]
- Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1; [Time frame: Estimated 2 years]
- Overall Survival (OS). [Time frame: Estimated 2 years]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT07489716 · SHR-1826-205