Testing SHR-1826 in locally advanced or metastatic 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

This trial tests whether SHR-1826 given by IV every three weeks can help people with locally advanced or metastatic non-small cell lung cancer that has progressed after prior systemic therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07489716 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter Phase II trial that gives the recommended dose of SHR-1826 by intravenous infusion once every 21-day cycle until protocol-defined discontinuation. The trial enrolls adults with histologically confirmed locally advanced or metastatic non-small cell lung cancer who have progressed on or were intolerant to prior systemic therapy and who have at least one measurable lesion by RECIST v1.1. Key assessments include tumor response, safety and tolerability, and pharmacokinetic measurements. Participants must provide archived or fresh tumor tissue and meet standard organ function and performance-status criteria.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed advanced or metastatic non-small cell lung cancer, ECOG 0–1, measurable disease, adequate organ function, available tumor tissue, and prior systemic therapy failure or intolerance are eligible.

Not a fit: Patients with symptomatic central nervous system or meningeal metastases, untreated spinal cord compression, active interstitial lung disease, severe cardiovascular/cerebrovascular disease, or unresolved high-grade adverse events from prior therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If SHR-1826 is effective, it could shrink tumors or slow disease progression in patients whose cancer has progressed after prior treatments.

How similar studies have performed: Related classes of targeted or immune-based therapies have shown benefit in NSCLC, but SHR-1826 itself is investigational and prior clinical evidence for this specific agent is limited.

Eligibility criteria

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;

Where this trial is running

Jinan, Shandong

• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yijun Jia

Conditions Non-Small Cell Lung Cancer