Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: a Multi - Omics Perspective

NCT ID: NCT06856798

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2028-02-09

Brief Summary

This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.

Conditions

NSCLC Stage IIIA/B; NSCLC Stage II

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PD-1/PD-L1 neoadjuvant therapy group

Patients with non - small cell lung cancer who are negative for driver genes such as EGFR and ALK and receive neoadjuvant immunotherapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• NSCLC, clinical tumor stage II-IIIB
• Without EGFR/ALK gene mutation
• Patient 18 years or older.
• Scheduled for neoadjuvant immunotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
• Life expectancy ≥ 12 weeks.
• Patient able to understand and sign written informed consent.

Exclusion Criteria

• With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
• With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.
• with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziming Li

OTHER

Sponsor Role: lead

Responsible Party

Ziming Li

Chief of the Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ziming Li

Role: CONTACT

liziming1980@163.com

+86 15216769608

References

Xu J, Wan R, Cai Y, Cai S, Wu L, Li B, Duan J, Cheng Y, Li X, Wang X, Han L, Wu X, Fan Y, Yu Y, Lv D, Shi J, Huang J, Zhou S, Han B, Sun G, Guo Q, Ji Y, Zhu X, Hu S, Zhang W, Wang Q, Jia Y, Wang Z, Song Y, Wu J, Shi M, Li X, Han Z, Liu Y, Yu Z, Liu AW, Wang X, Zhou C, Zhong D, Miao L, Zhang Z, Zhao H, Yang J, Wang D, Wang Y, Li Q, Zhang X, Ji M, Yang Z, Cui J, Gao B, Wang B, Liu H, Nie L, He M, Jin S, Gu W, Shu Y, Zhou T, Feng J, Yang X, Huang C, Zhu B, Yao Y, Yu J, Yao S, Shen R, Wang Z, Wang J. Circulating tumor DNA-based stratification strategy for chemotherapy plus PD-1 inhibitor in advanced non-small-cell lung cancer. Cancer Cell. 2024 Sep 9;42(9):1598-1613.e4. doi: 10.1016/j.ccell.2024.08.013.

Reference Type: BACKGROUND

PMID: 39255777 (View on PubMed)

Ai X, Jia B, He Z, Zhang J, Zhuo M, Zhao J, Wang Z, Zhang J, Fan Z, Zhang X, Li C, Jin F, Li Z, Ma X, Tang H, Yan X, Li W, Xiong Y, Yin H, Chen R, Lu S. Noninvasive early identification of durable clinical benefit from immune checkpoint inhibition: a prospective multicenter study (NCT04566432). Signal Transduct Target Ther. 2024 Dec 16;9(1):350. doi: 10.1038/s41392-024-02060-3.

Reference Type: BACKGROUND

PMID: 39676097 (View on PubMed)

Other Identifiers

IS25015

Identifier Type: -

Identifier Source: org_study_id