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

NCT07489716 | Recruiting Phase 2

• 1 other identifier: SHR-1826-205
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  once every 6 weeks, estimated 2 years

Secondary Outcomes (5)

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

  once every 6 weeks, estimated 2 years

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

  once every 6 weeks, estimated 2 years

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

  once every 6 weeks, estimated 2 years

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

  Estimated 2 years

• Overall Survival (OS).

  Estimated 2 years

Study Arms (1)

SHR-1826

EXPERIMENTAL

Drug: SHR-1826

Interventions

SHR-1826 DRUG

SHR-1826

SHR-1826

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yijun Jia

CONTACT

+0518-81220121; Yijun.jia@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-03

Locations

CN (1)