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

NCT06856798 | Not Yet Recruiting

• 1 other identifier: IS25015
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

Multi - Omics Biomarkers; Immunotherapy; Perioperative; ctDNA; MRD

Outcome Measures

Primary Outcomes (1)

• Pathological response after immune neoadjuvant therapy

  The primary evaluation indicators are pathological complete response (pCR) and major pathological response (MPR). MPR refers to the residual tumor cells in the surgically resected specimens being ≤ 10%, while pCR requires the complete disappearance of tumor cells.

  From enrollment to surgery at 18 weeks

Secondary Outcomes (2)

• 2-year Progression-Free Survival(PFS1)

  PFS of patients from the time of enrollment until two years

• 2-year Progression-Free Survival(PFS2)

  PFS from the start of adjuvant immunotherapy to 2 years.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziming Li: lead

Related Publications (2)

• 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.

  PMID: 39255777 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Boold，tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ziming Li

CONTACT

+86 15216769608; liziming1980@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Oncology Department

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: March 10, 2025
• Primary Completion: March 9, 2026
• Study Completion (Estimated): February 9, 2028
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share