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

May 12, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Affiliated Cancer Hospital of Shandong First Medical University
        • Principal Investigator:
          • Jinming Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1826
Drug: SHR-1826
SHR-1826

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ORR assessed by IRC according to RECIST v1.1 s）
Time Frame: once every 6 weeks, estimated 2 years
once every 6 weeks, estimated 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
Time Frame: once every 6 weeks, estimated 2 years
once every 6 weeks, estimated 2 years
Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
Time Frame: once every 6 weeks, estimated 2 years
once every 6 weeks, estimated 2 years
Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;
Time Frame: once every 6 weeks, estimated 2 years
once every 6 weeks, estimated 2 years
Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;
Time Frame: Estimated 2 years
Estimated 2 years
Overall Survival (OS).
Time Frame: Estimated 2 years
Estimated 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1826-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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