Evaluating chemotherapy with or without immune checkpoint inhibitors for lung cancer
Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
This study is testing whether adding immune checkpoint inhibitors to chemotherapy can help people with non-small cell lung cancer feel better and have fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (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 | NCT05059951 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and adverse events of immune checkpoint inhibitors used alone or in combination with chemotherapy for patients with non-small cell lung cancer. It involves a prospective approach where patients are divided into cohorts based on factors such as pathological type and treatment regimen. Tissue samples will be collected from participants to evaluate the tumor microenvironment. The study seeks to provide clinical evidence specifically for the Hunan province, where such data is currently limited.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed non-small cell lung cancer who are undergoing chemotherapy with or without immune checkpoint inhibitors.
Not a fit: Patients who do not meet the inclusion criteria or have conditions that preclude participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options and outcomes for lung cancer patients by identifying effective combinations of therapies.
How similar studies have performed: While there is existing evidence supporting the efficacy of checkpoint inhibitors combined with chemotherapy in other regions, this study aims to fill a gap in clinical evidence specific to Hunan province.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥18，Lung Cancer Confirmed by Histopathology 2. Treated with Chemotherapy with or Without Checkpoint Inhibitors. 3. ECOG 0 - 1. 4. Predicted survival ≥ 12 weeks. 5. Adequate bone marrow hematopoiesis and organ function 6. Presence of measurable lesions according to RECIST 1.1. 7. Subjects with stable brain metastases may be included in the study. Exclusion Criteria: Patients did not match for the Inclusion Criteria.
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.