Multi-omics blood and tissue testing to predict and monitor treatment response in small cell lung cancer

A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer: A Prospective, Non-interventional Study

This project will test whether combining multiple molecular tests on blood and tumor tissue can predict and track treatment response in people with newly diagnosed 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: NCT07026669 on ClinicalTrials.gov

What this trial studies

This prospective, single-center study will collect peripheral blood and paraffin-embedded tumor samples from treatment-naïve patients with limited- or extensive-stage small cell lung cancer before first-line therapy. Investigators will perform multi-omics sequencing on blood and tissue samples and analyze dynamic molecular changes in blood during treatment. They will use those data to build and validate predictive models and scoring systems for treatment efficacy and to define molecular subtypes. Secondary and exploratory analyses will examine model sensitivity/specificity across stages and search for candidate biomarkers and therapeutic targets.

Who should consider this trial

Good fit: Adults (≥18) with treatment-naïve limited- or extensive-stage small cell lung cancer, ECOG 0–1, expected survival ≥3 months, measurable disease, and willing to provide blood and paraffin tissue samples are ideal candidates.

Not a fit: Patients who have received prior systemic treatment, have mixed non-small cell histology, poor performance status, very limited life expectancy, or who cannot attend the Beijing site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could help clinicians predict who is likely to respond to therapy and use blood-based monitoring to detect changes earlier and personalize treatment decisions.

How similar studies have performed: Previous work has shown some single-omics biomarkers but limited clinical translation, and fully integrated multi-omics predictive and dynamic monitoring models remain largely experimental.

Eligibility criteria

Inclusion Criteria:

* Patients meeting the following criteria may have samples collected:

  1. Voluntary signing of informed consent;
  2. Age ≥18 years;
  3. Expected survival time ≥3 months;
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  5. Treatment-naïve limited-stage or extensive-stage SCLC confirmed by histology or cytology;
  6. Agreement to provide blood samples and paraffin-embedded samples;
  7. Measurable target lesions for efficacy evaluation.

Exclusion Criteria:

* Patients with any of the following conditions will be excluded from sample collection:

  1. Archived tumor tissue or pre-treatment tumor biopsy or histological examination showing previous histological or cytological evidence of non-small cell or small cell/non-small cell mixed components;
  2. Investigator-determined unsuitability for peripheral blood collection due to complications or other conditions;
  3. Active, known, or suspected autoimmune disease (excluding vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring only hormone replacement therapy, or conditions not expected to recur without external stimulation);
  4. Active tuberculosis (TB) infection based on chest X-ray, sputum examination, and clinical examination. Patients with active pulmonary TB infection history within the previous year should be excluded even if treated. Patients with active pulmonary TB infection history more than one year ago should also be excluded unless previous anti-TB treatment can be proven adequately effective;
  5. Comorbidities requiring immunosuppressive drug treatment, or requiring systemic or local corticosteroid use at immunosuppressive doses;
  6. Pregnancy or lactation;
  7. Positive 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 \> lower limit of detection at study center);
  8. History of severe neurological or psychiatric disorders, including but not limited to: dementia, depression, seizures, bipolar disorder, etc.;
  9. Use of any anti-tumor drugs before blood sample collection;
  10. Previous history of other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast cancer);
  11. Patients receiving live vaccines within 28 days before 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 Small Cell Lung Cancer