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

NCT ID: NCT06844474

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2028-02-29

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

SHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection

Group Type: EXPERIMENTAL

SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

Intervention Type: DRUG

Drug:

Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.

Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks.

Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.

Interventions

SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

Drug:

Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks.

Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.

Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks.

Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Song

Role: CONTACT

li.song@hengrui.com

0518-82342973

Other Identifiers

SHR-1826-203

Identifier Type: -

Identifier Source: org_study_id