OncoMatch/Clinical Trials/NCT06102057
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Is NCT06102057 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chemotherapy and Immunotherapy for stage iii non-small cell lung cancer.
Treatment: Chemotherapy · Immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression ≥ 1% (tumor proportion score; TPS) (≥ 1% TPS)
Histologically proven PD-L1-expression of ≥ 1% (tumor proportion score; TPS) in tumor sample as assessed in routine staging using a validated test such as Ventana SP236 assay
Disease stage
Required: Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cancer treatment for NSCLC
Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted.
Receipt of prior or current cancer treatment for NSCLC, including but not limited to, surgical resection, radiation therapy, investigational agents, chemotherapy, and monoclonal antibodies (mAbs). Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted.
Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, durvalumab, anti-PD-L2, therapeutic anticancer vaccines)
Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 (including durvalumab), and anti-PD-L2 antibodies, including therapeutic anticancer vaccines
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; Absolute neutrophil count >1.5 × 10^9/L; Platelet count >100 × 10^9/L
Kidney function
Measured creatinine clearance (CrCl) >40 mL/min or calculated CL >40 mL/min as determined by Cockcroft-Gault (using actual body weight)
Liver function
Serum bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN
Adequate bone marrow and organ function at enrolment * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count >1.5 × 10^9/L * Platelet count >100 × 10^9/L * Serum bilirubin ≤1.5 × upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN * Measured creatinine clearance (CrCl) >40 mL/min or calculated CL >40 mL/min as determined by Cockcroft-Gault (using actual body weight)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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