A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: SHR-1826

Study type: Interventional

Funder types: Industry

Identifiers

NCT07489716

SHR-1826-205

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

SHR-1826

Experimental group

Treatment:

Drug: SHR-1826