Radiotherapy approach for advanced lung cancer patients responding to immunotherapy and chemotherapy
Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy
This study is testing if skipping a certain part of radiation treatment can help advanced lung cancer patients who have responded to immunotherapy and chemotherapy avoid lung problems while still keeping their tumors under control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06037733 on ClinicalTrials.gov |
What this trial studies
This randomized study aims to evaluate the effects of omitting the clinical target volume (CTV) in primary tumor radiotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have responded to immunotherapy and chemotherapy. The study will assess outcomes related to pneumonitis, local tumor control, and overall survival. Previous findings suggest that omitting CTV radiation may reduce the incidence of pneumonitis without compromising local control and survival rates. The goal is to optimize treatment while preserving immune function to enhance the benefits of immunotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with advanced NSCLC who have shown a positive response to prior chemotherapy and immunotherapy.
Not a fit: Patients with tumor progression after therapy, specific genetic mutations, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced side effects and improved survival outcomes for patients with advanced NSCLC.
How similar studies have performed: Previous studies have indicated that omitting CTV radiation does not negatively impact local control or survival, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC); 2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend); 3. Age 18 to 80 years old, performance status 0-1; 4. measurable or evaluable lesions; 5. Survival expectancy is not less than 6 months; 6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function Exclusion Criteria: 1. tumor progress after therapy with immunotherapy and chemotherapy 2. EGFR, ALK, or ROS1 mutation; 3. Previous thoracic radiotherapy; 4. grade 2 or more immune-related adverse events after induction immunotherapy 5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ); 6. Pregnant or lactating women 7. undergoing other clinical trials; 8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes; 9. Patients with HIV positive and undergoing antiviral therapy; 10. Active tuberculosis
Where this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Guang Han, PhD — Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Guang Han, PhD
- Email: hg7913@hotmail.com
- Phone: +86 13886048178
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.