Actively Recruiting

Age: 18Years +
All Genders
NCT07057102

Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-09

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lung cancer is one of the diseases with the highest global incidence and mortality. Studies have confirmed that liquid biopsy markers such as minimal residual disease (MRD) detection in solid tumors, circulating tumor DNA (ctDNA), and T-cell receptor (TCR) have roles in monitoring disease status, prognostic evaluation, recurrence prediction, and guiding treatment decisions in NSCLC patients. Peripheral blood dynamic monitoring indicators have broad application prospects and may completely transform the treatment paradigm for NSCLC patients in the future. However, current limitations exist, including the need to improve the sensitivity of detection methods, the lack of uniform criteria for defining MRD positivity, the undetermined timing and cycle of MRD testing, and insufficient results from large-scale prospective clinical trials. Therefore, the transition of peripheral blood-based dynamic testing to routine clinical practice still requires results from large-scale prospective clinical trials. This study intends to conduct a prospective clinical trial enrolling NSCLC patients with different stages and treatment modalities (immunotherapy combined with chemotherapy, targeted therapy combined with chemotherapy, neoadjuvant therapy, adjuvant therapy). Based on peripheral blood and tumor tissue samples, it will systematically integrate multi-omics approaches including ctDNA testing, whole exome sequencing (WES), genome-wide methylation sequencing (GM-seq), and TCR-seq to carry out comprehensive, precise, and dynamic biomarker detection for efficacy monitoring and recurrence prediction, providing new methods and evidence for the clinical application of dynamic liquid biopsy monitoring in lung cancer.

CONDITIONS

Official Title

Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent voluntarily
  • Age 18 years or older
  • Expected life expectancy of 3 months or more
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Classified as stage II, III, or IV by AJCC TNM staging system (9th edition)
  • Willing to provide blood and pre-treatment paraffin-embedded tissue samples
  • Presence of evaluable target lesions for efficacy assessment
Not Eligible

You will not qualify if you...

  • Unsuitable for peripheral blood collection due to complications or other reasons
  • Active, known, or suspected autoimmune diseases (except certain conditions like vitiligo, type 1 diabetes, or stable hypothyroidism)
  • Active tuberculosis infection or history of active TB within the past year without effective treatment
  • Comorbidities requiring immunosuppressive drugs or corticosteroids at immunosuppressive doses
  • Pregnant or lactating women
  • Positive for HIV antibody, active hepatitis B or C infections above detection thresholds
  • History of severe neurological or psychiatric disorders such as dementia, depression, seizures, or bipolar disorder
  • Use of any anti-tumor drugs prior to blood sample collection
  • Previous other malignancies except certain in situ carcinomas and non-melanoma skin cancer
  • Received live vaccines within 28 days before blood sample collection

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

Z

Zhijie Wang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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