Testing SHR-1826 in locally advanced or metastatic non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yijun Jia
• Email: Yijun.jia@hengrui.com
• Phone: +0518-81220121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.