The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer

A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer

This study is an open-label, multicenter phase II clinical trial of adebelizumab combined with other anti-tumor therapies in patients with non-small cell lung cancer. The aim of this study was to evaluate the safety, tolerability and efficacy of adebelizumab combined with other anti-tumor therapies in patients with resectable non-small cell lung cancer ( NSCLC )

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection; Drug: Adebrelimab Injection combined with HRS-7058 Capsule

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanhua Huang; Phone Number: 0518-82342973; Email: Yanhua.Huang@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Shanghai Pulmonary Hospital
      • Principal Investigator: Chang Chen

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
2. At the time of signing the informed consent form, the age is 18-70 years old ( including both ends ), both men and women can.

The ECOG score was 0 or 1. 4. Patients with histopathologically or cytologically confirmed Stage II, IIIA, or select Stage IIIB (AJCC 9th edition) non-small cell lung cancer who are candidates for curative-intent R0 surgical resection.

5.Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.

6.Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.

7.According to the RECIST v1.1 standard, subjects must have measurable target lesions examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before the first administration.

8.There is sufficient hematology and organ function, as defined by the results of laboratory tests, to be completed within 7 days prior to the first dose of treatment : 9.Women of childbearing age must have a serum pregnancy test within 7 days before the first administration, and the result is negative. Women of childbearing age and men whose partners are women of childbearing age must agree to use an efficient method of contraception from the date of signing the informed consent to at least 26 weeks ( female subjects ) or 14 weeks ( male subjects ) after the last administration.

Exclusion Criteria:

1. Small cell lung cancer ( SCLC ) and NSCLC mixed tumors confirmed by histology or cytology contain non-NSCLC pathological types such as small cell components.

3.Have previously received systematic anti-tumor therapy for non-small cell lung cancer other than this study ( including clinical research drugs ) ; 4.Participants who had received or planned to receive local treatment such as chest radiotherapy or ablation ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PART A	Drug: Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection; Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection
Experimental: PART B	Drug: Adebrelimab Injection combined with HRS-7058 Capsule; Adebrelimab Injection combined with HRS-7058 Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection.	All results are expected to be obtained in the last participant three months after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	EFS is defined as the time from the first dose to any of the following events: any progression of disease precluding surgery; progression or recurrent disease based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after surgery; or death from any cause.	In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
Disease-free survival (DFS) as assessed byinvestigator	DFS is defined as the time from firste dose to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.	In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
Objective response rate (ORR): assessed by the investigator		In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant
Overall Survival (OS)	OS is defined as the time from first dose to death due to any cause.	In view of the relatively stable postoperative condition, the preliminary plan was collected until the end of the 5-year follow-up of the last participant

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1316-207

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