Finding biomarkers for lung cancer treatment with immune checkpoint inhibitors
Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
This study is testing if certain biological markers can help predict side effects in lung cancer patients receiving immune checkpoint inhibitors, with or without chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 12000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05055908 on ClinicalTrials.gov |
What this trial studies
This study aims to identify biomarkers that can predict adverse events in lung cancer patients treated with immune checkpoint inhibitors, either alone or in combination with platinum-based chemotherapy. Patients with histologically or cytologically confirmed lung cancer will be enrolled, and their adverse events will be evaluated by the principal investigator. Blood and formalin-fixed paraffin-embedded (FFPE) samples will be collected for further analysis, and an AI-based predictive model will be constructed to correlate adverse events with gene profiles.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed lung cancer who are being treated with immune checkpoint inhibitors.
Not a fit: Patients who do not meet the inclusion criteria or lack the necessary data for adverse event evaluation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient safety and personalized treatment strategies for lung cancer patients receiving immune checkpoint inhibitors.
How similar studies have performed: Other studies have explored biomarkers in cancer treatment, but this specific approach focusing on immune checkpoint inhibitors and AI modeling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed lung cancer. 4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy. 6\. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. Exclusion Criteria: Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
- Study coordinator: Yongchang Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
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.