Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06102057 | PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC | PHASE2 | RECRUITING | 110 | — | — | Jul 1, 2024 | Jun 1, 2028 | Dec 17, 2025 | 11 | Germany, Switzerland |
To assess the feasibility of an FDG-PET-based small volume accelerated chemoradiotherapy followed by immunotherapy with durvalumab compared to standard FDG-PET-based chemoradiotherapy followed by immunotherapy with durvalumab Completion rate defined as rate of patients having received: * the prescribed radiotherapy dose ± 2 fractions and * simultaneous platinum-based chemotherapy and · immunotherapy consolidation with durvalumab starting within 42 days after the last dose of chemoradiotherapy and * either at least 3 doses of durvalumab or less than 3 doses of durvalumab in case immunotherapy was permanently discontinued due to documented extrathoracic immune-related toxicity.
| Arm | Type | Description |
|---|---|---|
| Conventional Arm | ACTIVE_COMPARATOR | standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy |
| Experimental Arm | EXPERIMENTAL | FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy |
| Name | Type | Description |
|---|---|---|
| standard Radiotherapy | RADIATION | standard FDG-PET-based radiotherapy |
| Chemotherapy | DRUG | concurrent standard of care chemotherapy |
| Immunotherapy | DRUG | standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first. |
| Experimental Radiotherapy | RADIATION | FDG-PET-based small volume accelerated radiotherapy |
Inclusion Criteria: * Written informed consent * Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determi...