The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adebrelimab Injection combined with SHR-1826 Injection combined with SHR-8068 Injection, Adebrelimab Injection combined with HRS-7058 Capsule.
- Who it may be relevant to
- Registry conditions: Resectable Non-small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Study of Adebelizumab Combined With Other Anti-tumor Treatments as a Perioperative Treatment for Resectable Non-small Cell Lung Cancer
Overview
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 )
Interventions
- 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 - Drug Adebrelimab Injection combined with HRS-7058 Capsule
Adebrelimab Injection combined with HRS-7058 Capsule
Primary outcome measures
- Pathological complete response (pCR) rate: pCR is defined as the absence of any residual tumor at the time of surgical resection. [Time frame: All results are expected to be obtained in the last participant three months after surgery.]
Secondary outcome measures (4)
- Event-free survival (EFS) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
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
- 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 ;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT07704645 · SHR-1316-207