A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: SHR-1826; Drug: SHR-1316; Drug: SHR-9839; Drug: SHR-8068; Drug: Ametinib mesylate; Drug: BP-102; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yijun Jia; Phone Number: +86-18801784695; Email: yijun.jia@hengrui.com
• Study Contact Backup: Name: Tingting Lei; Phone Number: +86-18610051325; Email: Tingting.lei.tl6@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Principal Investigator: Shun Lu
      • Contact: Shun Lu; Phone Number: +86-13601813062; Email: shun_lu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed NSCLC.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Previous or co-existing malignancies.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Uncontrollable tumor-related pain.
5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
8. With poorly controlled or severe cardiovascular disease.
9. Active hepatitis B and hepatitis C.
10. Patients with a history of immunodeficiency.
11. Severe infection 30 days before the first dose.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: SHR-1826; SHR-1826 for injection.; Drug: SHR-1316; SHR-1316 for injection.; Drug: SHR-9839; SHR-9839 for injection.; Drug: SHR-8068; SHR-8068 for injection.; Drug: Ametinib mesylate; Ametinib mesylate.; Drug: BP-102; BP-102 for injection.; Drug: Carboplatin; Carboplatin for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recommended phase II dose (RP2D)	Screening up to study completion, an average of 1 year.
Adverse events (AEs)	Screening up to study completion, an average of 1 year.
Objective response rate (ORR)	Screening up to study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease control rate (DCR)	Screening up to study completion, an average of 1 year.
Duration of response (DoR)	Screening up to study completion, an average of 1 year.
Progression-free survival (PFS)	Screening up to study completion, an average of 1 year.
Overall survival (OS)	Screening up to study completion, an average of 1 year.
Drug resistant antibody (ADA) to SHR-1826	Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826	Screening up to study completion, an average of 1 year.
Blood concentration of free toxin	Screening up to study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): January 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Carboplatin
• Other Study ID Numbers: SHR-1826-201-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No