Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: A Multi - Omics Perspective
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NSCLC Stage IIIA/B, NSCLC Stage II. Basic parameters: 18 years — 80 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction of a Efficacy Stratification Prognostic and Prediction Model for Perioperative Immunotherapy in Non - Small Cell Lung Cancer Based on Multi - Omics Biomarkers
Overview
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.
Primary outcome measures
- Pathological response after immune neoadjuvant therapy [Time frame: From enrollment to surgery at 18 weeks]
Secondary outcome measures (2)
- 2-year Progression-Free Survival(PFS1) [Time frame: PFS of patients from the time of enrollment until two years]
- 2-year Progression-Free Survival(PFS2) [Time frame: PFS from the start of adjuvant immunotherapy to 2 years.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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, Ji PMID 39255777
- 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. PMID 39676097
Identifiers
NCT: NCT06856798 · IS25015