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Recruiting Phase 2

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

NCT07489716 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-04-29
Last updated
2026-05-13

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

SHR-1826 →

SHR-1826: SHR-1826

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • ORR assessed by IRC according to RECIST v1.1 s) — once every 6 weeks, estimated 2 years

Trial sites (1)

FacilityCityRegionStatus
Affiliated Cancer Hospital of Shandong First Medical University Jinan Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489716 on ClinicalTrials.gov ↗ ← All trials in China