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NCT Number: NCT07489716

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Jinming Yu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

SHR-1826

Drug

SHR-1826

Primary outcomes

  1. ORR assessed by IRC according to RECIST v1.1 s)

    Time frame: once every 6 weeks, estimated 2 years

Secondary outcomes

  1. Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;

    Time frame: once every 6 weeks, estimated 2 years

  2. Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;

    Time frame: once every 6 weeks, estimated 2 years

  3. Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;

    Time frame: once every 6 weeks, estimated 2 years

  4. Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;

    Time frame: Estimated 2 years

  5. Overall Survival (OS).

    Time frame: Estimated 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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