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AzTrials

Stage III Non-small Cell Lung CancerPhase 2PACCELIONCT06102057

PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC

A Phase 2 study testing standard Radiotherapy, Chemotherapy and Immunotherapy in people with Stage III Non-small Cell Lung Cancer and Locally Advanced, run by TheraOp at 11 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
standard Radiotherapy, Chemotherapy and Immunotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
11 sitesin 2 countries
Study dates
1 Jul 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 determined by the investigator
  • Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 2016))
  • Patients fit for simultaneous chemoradiotherapy and consolidation immunotherapy according to interdisciplinary consensus
  • 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
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
  • Tumor assessment by FDG-PET CT within 21 days prior to start of chemoradiotherapy.
  • Adequate pulmonary function test results
  • Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or >40% of predicted AND
  • Diffusing capacity of the lung for carbon monoxide (DLCO) >30% of predicted
  • Adequate bone marrow and organ function at enrolment
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count >1.5 × 109/L
  • Platelet count >100 × 109/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)
  • Body weight of >30 kg at enrolment
  • Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they are amenorrhoic for 12 months or more without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of exogenous hormonal treatments with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
  • Women ≥50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)
  • Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group during the treatment phase of this study and for at least 90 days after the last dose durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last

Who cannot join

  • Mixed small cell and NSCLC histology
  • Neuroendocrine tumor
  • Distant metastases
  • Malignant pleural effusion or pericardial effusion
  • Acute superior vena cava obstruction
  • 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.
Show all 37Show fewer
  • Receipt of live attenuated vaccine within 30 days prior to the start of therapy. Note: Patients, if enrolled, should not receive live vaccine during treatment phase and up to 30 days end of treatment
  • Major surgical procedure (as defined by the Investigator) within 28 days prior start of treatment.
  • 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
  • Current use of ongoing long-term immunosuppressive medication. The following are exceptions to this criterion
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • History of allogeneic organ transplantation
  • Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years at randomization may be included but only after consultation with the local study physician
  • Patients with celiac disease controlled by diet alone
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
  • Patients with oxygen dependence
  • Acute inflammation of mediastinal lymph nodes/mediastinal lymphadenopathy in the context of active pneumoconiosis, sarcoidosis or tuberculosis
  • History of another primary malignancy, except for
  • Basal cell carcinoma of the skin
  • Second malignancy diagnosed > 2 years prior to NSCLC diagnosis if after curative treatment without persistence or progression at baseline. Patients with a previous history of radiation therapy are eligible provided field overlap is minimal and the risk of toxicity to tissues in the overlapping region(s) is deemed to be acceptable by treating radiation oncologist.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • History of leptomeningeal carcinomatosis
  • Positive diagnostic test for hepatitis B (hepatitis B surface antigen) or hepatitis C (hepatitis C antibody or hepatitis C RNA)
  • Known active infection of tuberculosis or human immunodeficiency virus
  • Known allergy or hypersensitivity to concomitant chemotherapy and durvalumab or any of the excipients
  • Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the applying SmPCs
  • Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.
  • Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study
  • Participation in another clinical study with an investigational product during the 4 weeks prior to enrolment
  • Pregnancy or breast-feeding

Trial locations and contacts

11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Bernhard Remes, Dr. contact

+49 641 944 36 36

paccelio@theraop.de

Sascha Herzer contact

+49 641 944 36 36

sahe@alcedis.de

11 sites in 2 countries

Germany10 sites, 10 recruiting

  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 01307

    Rebecca Bütof, PD Dr. med.

    Recruiting

  • Universitätsklinikum Essen - Klinik für Strahlentherapie

    Essen, 45122

    Christoph Pöttgen, Prof. Dr. med.

    Not yet recruiting

  • Medical Center - University Of Freiburg, Department of Radiation Oncology

    Freiburg im Breisgau, 79106

    Tanja Schimek-Jasch, Dr.

    Recruiting

  • Universitätsmedizin Göttingen, Department for Radiotherapy and Radiooncology

    Göttingen, 37075

    Rami El Shafie, Prof. Dr.

    Recruiting

  • Universität des Saarlandes, Klinik für Strahlentherapie und Radioonkologie

    Homburg, 66421

    Markus Hecht, Prof. Dr.

    Recruiting

  • Kliniken Maria Hilf GmbH Mönchengladbach

    Mönchengladbach, 41063

    Ursula Nestle, Prof. Dr.

    Recruiting

  • Klinikum der Universitaet Muenchen AöR, Department of Radiotherapy and Radiation Oncology

    München, 81377

    Eze Chukwuka, Dr.

    Recruiting

  • Pius-Hospital Oldenburg, Hematology and Oncology

    Oldenburg, 26121

    Frank Griesinger, Prof. Dr.

    Recruiting

  • Vinzenz Von Paul Kliniken gGmbH, Klinik für Strahlentherapie und Palliativmedizin

    Stuttgart, 70199

    Thomas Hehr, Prof. Dr.

    Recruiting

  • Überörtliche Berufsausübungsgemeinschaft Troisdorf

    Troisdorf, 53840

    Ernst Rodermann, Dr. med.

    Recruiting

Other trials in Germany

Switzerland1 site, 1 recruiting

  • Universitätsspital Zürich

    Zurich, 8091

    Guckenberger Guckenberger, Prof. Dr.

    Recruiting

Other trials in Switzerland

About this study

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.

Being tested
standard Radiotherapy, Chemotherapy, Immunotherapy, Experimental Radiotherapy
Keywords
chemoradiotherapy, immunotherapy, small volume accelerated chemoradiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard RadiotherapyRadiation

    Also called standard

    standard FDG-PET-based radiotherapy

  • ChemotherapyDrug

    Also called standard

    concurrent standard of care chemotherapy

  • ImmunotherapyDrug

    Also called standard

    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 RadiotherapyRadiation

    Also called Experimental

    FDG-PET-based small volume accelerated radiotherapy

Study groups in NCT06102057
Study groupRoleWhat they receive
Conventional ArmActive comparatorstandard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy
Receives: Radiation: standard Radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy
Experimental ArmExperimentalFDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy
Receives: Drug: Chemotherapy; Drug: Immunotherapy; Radiation: Experimental Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the Completion rate of Experimental Arm to Conventional Arm

    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.

    Measured: approximately 22 weeks after start of radio-chemotherapy

Secondary outcomes (13)

  1. Comparison of the Occurrence of adverse events and serious events of Experimental Arm to Conventional Arm

    To assess the safety and tolerability of an FDGPET- based small volume accelerated chemoradiotherapy followed by immunotherapy with durvalumab compared to standard FDG-PET-based chemoradiotherapy followed by immunotherapy with durvalumab

    Occurrence of adverse events and serious events:

    • adverse events grade ≥ 3 (according to NCI CTCAE v5.0)
    • SAEs
    • Unexpected AEs

    Measured: up to 78 weeks

  2. Comparison of the Time to locoregional progression of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • Time to locoregional progression

    Measured: time from randomization to progression in the primary tumor or any of mediastinal lymph nodes, up to 143,5 weeks

  3. Comparison of the Time to locoregional in-RT-field progression of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • Time to locoregional in-RT-field progression

    Measured: time from rando to progression in primary tumor or mediastinal lymph nodes within the target volume, up to 143,5 weeks

  4. Comparison of the Time to locoregional out-of-RT-field progression of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • Time to locoregional out-of-RT-field progression

    Measured: time from rando to progression in mediastinal lymph nodes outside the target volume, up to 143,5 weeks

  5. Comparison of the Time to distant progression time from rando to appearance of metastases elsewhere of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • Time to distant progression time from rando to appearance of metastases elsewhere

    Measured: time from rando to appearance of metastases elsewhere, up to 143,5 weeks

  6. Comparison of the PFS of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • PFS

    Measured: time from rando to disease progression or death by any cause, up to 143,5 weeks

  7. Comparison of the OS of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • OS

    Measured: time from rando to death by any cause, up to 143,5 weeks

  8. Comparison of the ORR of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • ORR

    Measured: Objective response rate defined as the proportion of randomized patients with best response of complete or partial response, up to 143,5 weeks

  9. Comparison of the DCR of Experimental Arm to Conventional Arm

    Assess efficacy of FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to standard FDG-PET-based CRT followed by immunotherapy in terms of time to locoreg. progression, time to locoreg. in- and out-of-RTfield progress

    • DCR

    Measured: Disease control rate defined as the proportion of rando patients with best response of complete response, partial response, or stable disease, up to 143,5 weeks

  10. Comparison of the Change in symptoms of Experimental Arm to Conventional Arm

    Assess symptoms and patient-reported QoL in patients receiving an FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to patients receiving standard FDG-PET-based CRT followed by immunotherapy

    1. Change in symptoms assessed with the EORTC QLQ-C30
    2. Change in symptoms assessed with the EORTC QLQ-LC13

    The results of the questionnaire are usually presented as scale scores, ranging from 0 to 100. Higher scores on the symptom scales indicate a worse quality of life.

    Measured: up to 143,5 weeks

  11. Comparison of the Change in functioning of Experimental Arm to Conventional Arm

    Assess symptoms and patient-reported QoL in patients receiving an FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to patients receiving standard FDG-PET-based CRT followed by immunotherapy

    1. Change in functioning assessed with the EORTC QLQ-C30
    2. Change in functioning assessed with the EORTC QLQ-LC13

    The results of the questionnaire are usually presented as scale scores, ranging from 0 to 100. Higher scores on the functional scales indicate a better quality of life.

    Measured: up to 143,5 weeks

  12. Comparison of the Change in global health-status/QoL of Experimental Arm to Conventional Arm

    Assess symptoms and patient-reported QoL in patients receiving an FDG-PET-based smallvolumeaccelerated CRT followed by immunotherapy compared to patients receiving standard FDG-PET-based CRT followed by immunotherapy

    1. Change in global health-status/QoL assessed with the EORTC QLQ-C30
    2. Change in global health-status/QoL assessed with the EORTC QLQ-LC13

    The results of the questionnaire are usually presented as scale scores, ranging from 0 to 100. Higher scores on the global health and quality of life scale indicate a better quality of life.

    Measured: up to 143,5 weeks

  13. To assure radiotherapy quality in terms of percentage of patients without major protocol deviations of ≥85%

    Percentage of patients without major protocol deviations regarding radiotherapy quality

    Measured: up to 55 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start1 Jul 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy)
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06102057
Sponsor's protocol ID
ESR-21-21536
Other IDs
2022-003408-33, ARO 2023-06
Acronym
PACCELIO
Status last verified
Dec 2025
First submitted
8 Sep 2023
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shafie RE, Willmann J, Gkika E, Schimek-Jasch T, Miederer M, Bozorgmehr F, Griesinger F, Manapov F, Christopoulos P, Hehr T, Hecht M, Butof R, Stuschke M, Guckenberger M, Schmid-Bindert G, Meiners J, Herzer S, Hartmann S, Lamche J, Rieken S, Nestle U. FDG-PET/CT based small volume accelerated immuno chemoradiotherapy in locally advanced NSCLC (PACCELIO) - a randomized, open-label, multicenter phase II trial protocol. BMC Cancer. 2026 Apr 17;26(1):494. doi: 10.1186/s12885-026-15901-x.

    PubMed 41992146

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing standard Radiotherapy, Chemotherapy and Immunotherapy in people with Stage III Non-small Cell Lung Cancer and Locally Advanced, run by TheraOp at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bernhard Remes, Dr. (+49 641 944 36 36, paccelio@theraop.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the Completion rate of Experimental Arm to Conventional Arm (time frame: approximately 22 weeks after start of radio-chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06102057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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