A Multi-omics Sequencing-based Model for Predicting Efficacy and Dynamic Monitoring of Treatment in Small Cell Lung Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to predict how well treatments will work for people with small cell lung cancer (SCLC), a fast-growing type of lung cancer that is often hard to treat. Researchers are using advanced lab techniques that look at different types of biological information (“multi-omics”) from blood and tissue samples to create a model that can help doctors better understand how a patient’s cancer might respond to treatment and track changes during therapy. This could lead to more personalized care and improve monitoring of the disease over time.

People eligible for this study are adults (18 years or older) who have just been diagnosed with small cell lung cancer and have not yet started treatment. They should be in generally good health (able to carry out daily activities) and expected to live at least three months. Participants will be asked to provide blood and tumor tissue samples, which will be used for detailed testing. The study is currently recruiting and welcomes all genders. Some conditions, like other serious illnesses or prior cancer treatments, may exclude someone from participating. If you join, you can expect regular sample collections to help doctors learn more about your cancer and how it changes with treatment.

Gender

ALL

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.