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

Applications of Multiple Omics Sequencing Technologies in Predicting the Efficacy and Monitoring the Recurrence of Non-Small Cell Lung Cancer: A Prospective, Non-Interventional Study

This study will test whether combining different sequencing tests on blood and tumor tissue can detect minimal residual disease and help predict treatment response and recurrence for people with stage II–IV non‑small cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07057102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with histologically or cytologically confirmed stage II–IV NSCLC, ECOG performance status 0–1, expected survival ≥3 months, who can provide pre‑treatment tissue and serial blood samples and have evaluable target lesions.

Not a fit: Patients who cannot provide blood or tissue samples, have excluded active infections or autoimmune conditions, very poor performance status, or only early‑stage disease are unlikely to gain direct benefit from this observational work.

Why it matters

Potential benefit: If successful, the approach could enable earlier detection of recurrence and more personalized treatment decisions, potentially avoiding unnecessary therapy or prompting timely interventions.

How similar studies have performed: Smaller studies and pilot data have shown promise for ctDNA/MRD and TCR monitoring in NSCLC, but large‑scale prospective validation is still limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Non Small Cell Lung Cancer; Non-small cell lung cancer; ctDNA; MRD