At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III disease
- ✓Fit for simultaneous chemoradiotherapy and consolidation immunotherapy per interdisciplinary consensus
- ✓PD-L1 expression ≥1% tumor proportion score (TPS) in tumor sample by validated test
- ✓Age ≥18 years at time of informed consent
- ✕Mixed small cell and NSCLC histology
- ✕Neuroendocrine tumor
- ✕Distant metastases
- ✕Malignant pleural effusion or pericardial effusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06102057Phase 2RecruitingMonitorUpdated 6mo ago · Completion was 1mo agoPACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
In Brief
A Phase 2 clinical trial evaluating standard Radiotherapy, Chemotherapy, and 2 other interventions for Stage III Non-small Cell Lung Cancer and 2 related conditions. Currently recruiting, targeting 110 participants across 11 sites in 2 countries.
Signals
Detailed Summary
Multinational, randomized, controlled, open-label, multicenter phase II trial. Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive 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. After end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.
Study Details
Timeline
Interventions
standard FDG-PET-based radiotherapy
concurrent standard of care chemotherapy
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.
FDG-PET-based small volume accelerated radiotherapy