Combining blood and tumor sequencing to predict response and recurrence in non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect pre‑treatment tumor tissue and serial peripheral blood samples to apply multiple omics sequencing technologies, including circulating tumor DNA (ctDNA) and T‑cell receptor (TCR) analysis. Participants will be adults with histologically confirmed stage II–IV NSCLC and good performance status, and samples will be used to track dynamic blood markers over time. The aim is to determine whether these liquid‑biopsy markers can reliably indicate treatment efficacy, detect minimal residual disease (MRD), and predict recurrence. Results are intended to inform timing, sensitivity thresholds, and clinical use of peripheral blood monitoring in routine care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily signed the informed consent;
2. Aged 18 years or older;
3. Expected life expectancy of ≥3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1);
5. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) patients;
6. Classified as stage II, III, or IV according to the AJCC TNM staging system (9th edition);
7. Willing to provide blood samples and pre-treatment paraffin-embedded tissue samples;
8. With evaluable target lesions for efficacy assessment.

Exclusion Criteria

1. In the investigator's opinion, unsuitable for peripheral blood collection due to complications or other circumstances;
2. Active, known, or suspected autoimmune diseases (except vitiligo, type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to relapse without external stimulation);
3. Active tuberculosis (TB) infection confirmed by chest X-ray, sputum examination, and clinical physical examination. Patients with a history of active TB infection within the past 1 year, even if treated, will be excluded. Patients with a history of active TB infection more than 1 year ago will also be excluded unless they can demonstrate that previous antitubercular treatment was fully effective;
4. Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or local corticosteroids at immunosuppressive doses;
5. Pregnant or lactating;
6. Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg-positive and HBV-DNA \> 10³ copies/ml), or hepatitis C virus infection (HCV antibody-positive and HCV-RNA \> the lower limit of detection at the study center);
7. History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
8. Use of any antitumor-active drugs prior to blood sample collection;
9. Previous history of other malignancies (excluding non-melanoma skin cancer and the following in situ carcinomas: bladder, stomach, colon, endometrium, cervix/dysplasia, melanoma, or breast cancer);
10. Administration of live vaccines within 28 days prior to blood sample collection.

Where it's running

• 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 Recruiting

Study contacts

• Study coordinator: Zhijie Wang, MD
• Email: jie_969@163.com
• Phone: +8613466323860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Patient-specific MRD liquid biopsy for resected NSCLC

  This study tests a personalized MRD blood and bronchial washing test after surgery to see if it can signal recurrence earlier in people with resected NSCLC.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do and 2 other locations · NCT07921888

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Dato-DXd in solid tumors (Urothelial Cancer and KRAS-mutant NSCLC) in two sub-studies

  This study tests Datopotamab Deruxtecan (Dato-DXd) alone or with other cancer drugs in people with urothelial cancer or KRAS-mutant non-small cell lung cancer.

  Recruiting Phase 1/2 Daiichi Sankyo · Taichung · NCT07890714

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

  This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.

  Recruiting Phase 2 Hansoh BioMedical R&D Company · Wuhan, Hubei · NCT07824882

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.