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Non-small Cell Lung CancerPUMANCT05237453

Pulmonary Magnetic Resonance-guided Online Adaptive Radiotherapy of Locally Advanced Non-Small Cell Lung Cancer

A study testing Photons in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 3 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such individualized treatment approaches can lead to reduced toxicity and potentially better local tumor control for patients with LA-NSCLC in the future. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Photons
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesGermany
Study dates
23 Jun 2022to 1 Mar 2028
Phase
Interventional
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

  • Histologically-proven non-small cell lung cancer (NSCLC)
  • Stage III A - C according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification
  • Indication for definitive thoracic chemoradiotherapy
  • Age ≥ 18 years
  • ECOG 0 - 2
  • Adequate pulmonary function for chemoradiotherapy confirmed by a current pulmonary function test (≤ 6 weeks from treatment start)
Show all 12Show fewer
  • Ability to lie still on the MR-linac table for at least one hour
  • Ability to hold one's breath for at least 20 seconds
  • Successful completion of an MR-guided treatment simulation
  • For women with childbearing potential: adequate contraception
  • Ability of the patient to understand character and individual consequences of the clinical trial
  • Written informed consent (must be available before enrolment in the trial)

Who cannot join

  • Involvement of supraclavicular lymph nodes (supraclavicular N3)
  • Additional pulmonary lesions (T3 - 4 due to additional lesion in the same or another lobe)
  • Previous radiotherapy of the lung and mediastinum, if previous and current target volumes overlap
  • Patients who have not yet recovered from acute toxicities of prior therapies
  • Contraindications against performing MRI scans (e.g. pacemakers or other implants making MRI impossible)
  • Pregnant or lactating women
  • Participation in another competing clinical study or observation period of competing trials
  • Refusal of the patients to take part in the study

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • University Hospital of Heidelberg, Radiation Oncology

    Heidelberg, 69120

  • Ludwig-Maximilian-Universität München

    Münich, Bavaria, 81377

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such individualized treatment approaches can lead to reduced toxicity and potentially better local tumor control for patients with LA-NSCLC in the future. PUMA is an early clinical trial, which aims to demonstrate the feasibility of MR-guided online ART to locally-advanced NSCLC. In a second step, the investigators aim to use the data from this feasibility trial to design and launch a further phase I/II clinical study that directly compares the benefits of MR-guided online ART of LA-NSCLC to CT-based (A)RT approaches.

Read the detailed description

Non-small cell lung cancer (NSCLC) is very common and carries the highest mortality of all malignant diseases (350.000 - 400.000 deaths per year in the European Union). In specific, the 5-year overall survival rate of locally-advanced NSCLC (LA-NSCLC) is merely 20%. One reason for this dismal prognosis is the lack of effective treatment options. Since most patients with LA-NSCLC are not candidates for a tumor resection, definitive (chemo)radiotherapy (C)RT with consecutive immunotherapy (IT) is the treatment of choice according to national and international guidelines. However, local tumor relapse remains a major pattern of recurrence in approx. 30% of cases. Furthermore, many patients cannot benefit from chemotherapy due to multiple comorbidities, and application of IT requires an initial tumor response to (C)RT and absence of higher-grade pulmonary toxicity. Consequently, radiotherapy is a cornerstone in the locally ablative treatment of LA-NSCLC and essentially influences the course of the further treatment. MR-guided radiotherapy is an innovative technique which supports sophisticated approaches towards pulmonary adaptive radiotherapy (ART). Such adaptive radiation approaches allow highly individualized thoracic radiotherapy with dose distributions tailored to the interfractional changes in tumor geometry and anatomy of surrounding OARs. Therefore, MR-guided ART has the potential to optimize the balance between intensified target volume dose and sparing of vulnerable OARs. This prospective, multicenter clinical trial is desinged to demonstrate the clinical feasibility and gain first data on the safety of MR-guided online ART to LA-NSCLC. Based on the investigators extensive experience with MR-guided RT of early-stage NSCLC and lung metastases, the invesitgators hypothesize that MR-guided online ART to LA-NSCLC can be performed successfully in ≥ 80% of patients with a mean time < 90 minutes. The investigators plan to include 30 patients with LA-NSCLC in Union for International Cancer Control (UICC) stage IIIA-C at three German university hospitals (Uniklinikum Heidelberg, Uniklinikum LMU München, Uniklinikum Tübingen). Patients will receive MR-guided online ART, which includes gated dose delivery as well as online plan adaptation once weekly or in case major anatomical changes are detected on daily MR-imaging. Patients will be followed-up to assess toxicity, tumor control (by means of thoracic CT- and MR-imaging) and patient-reported outcomes for 24 months after treatment.

Being tested
Photons
Keywords
lung cancer, adaptive Radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • PhotonsRadiation

    MR-guided adaptive radiotherapy

Study groups in NCT05237453
Study groupRoleWhat they receive
MR-guided adaptive radiotherapyExperimentalPatients receive Photon radiotheray as an MR-guided adaptive radiotherapy
Receives: Radiation: Photons

What is being measured

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

  1. clinical feasibility -1-

    successfully completed online adapted RT fractions

    Measured: through study completion, an average of 2 years

  2. clinical feasibility -2-

    treatment time for online adapted RT fractions

    Measured: through study completion, an average of 2 years

Secondary outcomes (7)

  1. acute side effects

    changes in toxicity according to CTCAE V5.0

    Measured: 3 months from treatment start

  2. subacute side effect

    changes in toxicity according to CTCAE V5.0

    Measured: 6 months from treatment start

  3. chronic side effect

    changes in toxicity according to CTCAE V5.0

    Measured: through study completion, at least 24 months

  4. Local tumor control

    time from treatment start until in-field tumor recurrence

    Measured: through study completion, at least 24 months

  5. Progession free survival

    time from treatment start until death or progression of tumor disease

    Measured: through study completion, at least 24 months

  6. Overall survival

    time from treatment start until death

    Measured: through study completion, at least 24 months

  7. Longitudinal pulmonary function

    changes in forced exspiratory volume in 1st second (FEV1s), vital capacity (vc), etc.

    Measured: through study completion, at least 24 months

Timeline

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

  1. First posted14 Feb 2022
  2. Study start23 Jun 2022
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05237453
Sponsor's protocol ID
RadOnk-PUMA_2021
Acronym
PUMA
Status last verified
Mar 2026
First submitted
13 Jan 2022
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Regnery S, de Colle C, Eze C, Corradini S, Thieke C, Sedlaczek O, Schlemmer HP, Dinkel J, Seith F, Kopp-Schneider A, Gillmann C, Renkamp CK, Landry G, Thorwarth D, Zips D, Belka C, Jakel O, Debus J, Horner-Rieber J. Pulmonary magnetic resonance-guided online adaptive radiotherapy of locally advanced: the PUMA trial. Radiat Oncol. 2023 May 4;18(1):74. doi: 10.1186/s13014-023-02258-9.

    PubMed 37143154

Questions about this trial

What is this clinical trial studying?

A study testing Photons in people with Non-small Cell Lung Cancer, run by University Hospital Heidelberg at 3 sites in Germany.

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 12 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical feasibility -1- (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 NCT05237453, 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 9 Mar 2026.

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