Analyzing the microenvironment of lung cancer and resistance to immunotherapy
Analysis of the Microenvironment of Lung Cancer and Exploration of the Mechanism of Resistance to Immunotherapy
This study is testing how different features of lung cancer tumors and their surroundings affect how well patients respond to immunotherapy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT05636605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct a multiomics analysis, including genomics, proteomics, and single-cell RNA sequencing, of tumor tissue and blood from lung cancer patients. The goal is to analyze tumor heterogeneity and map the tumor microenvironment to explore mechanisms of sensitivity and resistance to anti-PD-1/PD-L1 antibodies. By characterizing the entire tumor ecosystem, the study seeks to identify predictive biomarkers for immunotherapy responses and understand the individualized nature of treatment outcomes in lung cancer patients.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of lung cancer who have never received any antineoplastic therapy.
Not a fit: Patients with active autoimmune diseases requiring systemic treatment or those currently participating in interventional clinical research may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved precision medicine approaches for lung cancer immunotherapy, enhancing treatment efficacy for patients.
How similar studies have performed: Other studies have shown promise in utilizing multiomics approaches to understand cancer microenvironments, suggesting potential for success in this novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathology or hemology diagnostics of lung cancer * Patients have never received any antineoplastic therapy Exclusion Criteria: * Within 5 years or at the same time, there are other active malignancies * Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration * Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration * The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent) * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Where this trial is running
Yiwu, Zhejiang
- The Fourth Affiliated Hospital of Zhejiang University — Yiwu, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Kai Wang, PhD — The Fourth Affiliated Hospital of Zhejiang University
- Study coordinator: Kai Wang, PhD
- Email: doctorhuxi@163.com
- Phone: 13957158572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.