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

NCT07704645 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1316-207
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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 )

Conditions

Resectable Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Event-free survival (EFS)

  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

  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)

  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

Study Arms (2)

PART A

EXPERIMENTAL

Drug: Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection

PART B

EXPERIMENTAL

Drug: Adebrelimab Injection combined with HRS-7058 Capsule

Interventions

Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection DRUG

Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection

PART A

Adebrelimab Injection combined with HRS-7058 Capsule DRUG

Adebrelimab Injection combined with HRS-7058 Capsule

PART B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ;
• 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.
• Combined genetic requirements : non-squamous cell carcinoma subjects must undergo EGFR gene detection and ALK gene and or immunohistochemical detection.
• Can provide tumor tissue specimens, which can be archived or freshly obtained specimens for biomarker detection.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Central Study Contacts

Yanhua Huang

CONTACT

0518-82342973; Yanhua.Huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)