Actively Recruiting
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Led by TheraOp · Updated on 2025-12-17
110
Participants Needed
11
Research Sites
204 weeks
Total Duration
On this page
Sponsors
T
TheraOp
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Patients of any sex or gender aged 18 years or older at consent
- Willing and able to follow study visits, treatment, lab tests, and requirements
- Histologically or cytologically confirmed locally advanced, unresectable Stage III NSCLC
- Fit for simultaneous chemoradiotherapy and consolidation immunotherapy
- Tumor PD-L1 expression of 1% or higher by validated test
- ECOG performance status 0 or 1 at enrollment
- FDG-PET CT tumor assessment within 21 days before chemoradiotherapy start
- Adequate lung function with FEV1 ≥1.0 L or >40% predicted and DLCO >30% predicted
- Adequate bone marrow and organ function (Hemoglobin ≥9.0 g/dL, neutrophils >1.5 x10⁹/L, platelets >100 x10⁹/L, bilirubin ≤1.5 x ULN, ALT/AST ≤2.5 x ULN, creatinine clearance >40 mL/min)
- Body weight over 30 kg at enrollment
- Post-menopausal status or negative pregnancy test for women of childbearing potential
- Agreement to use highly effective contraception during treatment and for specified periods after last dose
You will not qualify if you...
- Mixed small cell and NSCLC histology
- Neuroendocrine tumor
- Presence of distant metastases
- Malignant pleural or pericardial effusion
- Acute superior vena cava obstruction
- Prior or current cancer treatment for NSCLC, except limited prior surgery for early NSCLC
- Live attenuated vaccine within 30 days before therapy
- Major surgery within 28 days before treatment start
- Prior immune-mediated therapy or therapeutic anticancer vaccines
- Current long-term immunosuppressive medication except specified exceptions
- History of allogeneic organ transplantation
- Active or prior autoimmune or inflammatory disorders with specified exceptions
- Uncontrolled illness or conditions limiting study compliance
- Oxygen dependence
- Acute mediastinal lymph node inflammation due to specific conditions
- History of other primary malignancies except certain treated cancers
- History of leptomeningeal carcinomatosis
- Positive hepatitis B or C test
- Active tuberculosis or HIV infection
- Allergy to chemotherapy, durvalumab, or excipients
- Contraindication to platinum-based chemotherapy
- Disease suitable for surgical treatment
- Concurrent enrollment in other interventional clinical studies
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
2
Universitätsklinikum Essen - Klinik für Strahlentherapie
Essen, Germany, 45122
Not Yet Recruiting
3
Medical Center - University Of Freiburg, Department of Radiation Oncology
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
4
Universitätsmedizin Göttingen, Department for Radiotherapy and Radiooncology
Göttingen, Germany, 37075
Actively Recruiting
5
Universität des Saarlandes, Klinik für Strahlentherapie und Radioonkologie
Homburg, Germany, 66421
Actively Recruiting
6
Kliniken Maria Hilf GmbH Mönchengladbach
Mönchengladbach, Germany, 41063
Actively Recruiting
7
Klinikum der Universitaet Muenchen AöR, Department of Radiotherapy and Radiation Oncology
München, Germany, 81377
Actively Recruiting
8
Pius-Hospital Oldenburg, Hematology and Oncology
Oldenburg, Germany, 26121
Actively Recruiting
9
Vinzenz Von Paul Kliniken gGmbH, Klinik für Strahlentherapie und Palliativmedizin
Stuttgart, Germany, 70199
Actively Recruiting
10
Überörtliche Berufsausübungsgemeinschaft Troisdorf
Troisdorf, Germany, 53840
Actively Recruiting
11
Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
B
Bernhard Remes, Dr.
CONTACT
S
Sascha Herzer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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