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

Phase 2

Recruiting

• Conditions: NSCLC
• Interventions: Drug: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

• Registration Number: NCT06844474
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-25
• Study Start: 2025-03-07
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-08-31
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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;
11. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	SHR-1826；Adebrelimab；SHR-8068；Bevacizumab	SHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)	approximately 2 years
Overall response rate (ORR)	approximately to 2 years

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	approximately to 2 years
Disease control rate (DCR)	approximately to 2 years
Progression-free survival (PFS)	approximately to 2 years
Overall survival (OS)	approximately to 5 years after last subject enrolled

Trial Locations

Locations (1)

Chinese People's Liberation Army (PLA) General Hospital; 🇨🇳 Beijing, Beijing, China