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NCT Number: NCT06856798

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pathological response after immune neoadjuvant therapy

    Time frame: From enrollment to surgery at 18 weeks

    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.

Secondary outcomes

  1. 2-year Progression-Free Survival(PFS1)

    Time frame: PFS of patients from the time of enrollment until two years

    Mainly evaluate the PFS of patients from the time of enrollment until two years later.

  2. 2-year Progression-Free Survival(PFS2)

    Time frame: PFS from the start of adjuvant immunotherapy to 2 years.

    Mainly evaluate the patient's PFS from the start of adjuvant immunotherapy to 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Ziming Li

Other

Registry information

Official study title

Construction of a Efficacy Stratification Prognostic and Prediction Model for Perioperative Immunotherapy in Non - Small Cell Lung Cancer Based on Multi - Omics Biomarkers

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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