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

NCT06844474 | Recruiting Phase 2

• 1 other identifier: SHR-1826-203
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)

  approximately 2 years

• Overall response rate (ORR)

  approximately to 2 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Arm A

EXPERIMENTAL

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

Drug: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

Interventions

SHR-1826；Adebrelimab；SHR-8068；Bevacizumab 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.

Arm A

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Central Study Contacts

Li Song

CONTACT

0518-82342973; li.song@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: February 19, 2025
• First Posted: February 25, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 29, 2028
• Last Updated: March 19, 2025

Record last verified: 2025-02

Locations

CN (1)