Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and C
Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires furthe
| Condition(s) | Neoadjuvant Therapy, Concurrent Chemoradiotherapy, Immunotherapy, Locally Advanced Non-Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients. |
| Who can participate | Inclusion Criteria: * Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant. * Age Range: Male or female patients aged 18 to 75 years. * Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis. * Previous Treatment: Patients must not have received prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy. * Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived. * Life Expectancy: Patients must have an expected survival of at least 12 weeks. * Perform |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2024-11-30 |
| NCT ID | NCT06734702 |
| Official listing | https://clinicaltrials.gov/study/NCT06734702 |