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A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC

NCT06844474•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
•2. ECOG performance score of 0-1.
•3. Life expectancy ≥ 3 months.
•4. Have at least one measurable tumor lesion per RECIST v1.1.
•5. Subjects with histologically confirmed locally advanced or metastatic NSCLC.
•6. Good level of organ function.
•7. Provide archived or fresh tumor tissue for vendor test.

Exclusion Criteria

•1. Subjects with active central nervous system metastases or meningeal metastases;
•2. History of serious cardiovascular and cerebrovascular diseases;
•3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
•4. Severe infection within 4 weeks prior to the first dose;
•5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
•6. Subjects with uncontrolled tumor-related pain;
•7. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
•8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
•9. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
•10. History of immunodeficiency, including a positive HIV test;
+1 more criteria

Locations (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 7, 2025

Primary Completion Date

August 31, 2026

Completion Date

February 29, 2028

Last Updated

March 19, 2025

Enrollment

300

ESTIMATED participants

Conditions

NSCLC

Interventions

SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

DRUG

Contacts

Li Song

CONTACT

0518-82342973 li.song@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

Inclusion Criteria

Exclusion Criteria

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