Partial high-dose tumor irradiation combined with immunotherapy for unresectable lung adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The protocol combines high-dose partial tumor irradiation (PTI), delivering ablative doses (typically 20–25 Gy per fraction) to the central bulky tumor while sparing the peritumoral immune microenvironment (PIM), with an immune checkpoint inhibitor (ICI). It targets adults with large, unresectable lung adenocarcinomas who have relapsed after or are unsuitable for standard therapies, offering PTI+ICI as a rechallenge or alternative to purely palliative care. Prior research with PTI alone showed safety and immunomodulatory signals, and this trial will monitor tumor control, immune markers, and safety when PTI is paired with systemic ICI. Treatments and follow-up are delivered at a single center with scheduled imaging and blood tests to track response and toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent
2. Biopsy proven unresectable lung adenocarcinoma
3. Ineligibility for surgery and conventional curative (whole tumor) radiotherapy, and relapsed/refractory to any previous standard of care therapy including ICI
4. Age ≥ 18 years,
5. Female patients must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) OR women of fertile age must have adequate conception prevention measures and must have a negative serum pregnancy test upon study entry,
6. Patient is willing and able to comply with the follow up including scheduled visits and examinations,
7. Adequate immune blood profile (not being immunodepressed): Leucocyte count ≥4000, Neutrophils count ≥1000.
8. PDL-1 ≥ 1%

Exclusion Criteria:

1. Patients with resectable/curable lung cancer
2. Tumors suitable for the standard of care therapies including surgery or conventional curative (whole tumor) radio-chemotherapy
3. Lung cancer histology other than adenocarcinoma
4. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
5. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, (1)
6. Patients with uncontrolled seizures.
7. Inadequate immune blood profile (being potentially immunodepressed): Leucocyte count \<4000, Neutrophils count \<1000.
8. PDL-1 \< 1%

Where it's running

• Radiation Oncology Department
  Krems, Austria, Austria Recruiting

Study contacts

• Principal investigator: Slavisa Tubin, MD — University Clinic Krems, Radiation Oncology Department
• Study coordinator: Slavisa Tubin, MD
• Email: slavisa.tubin@krems.lknoe.at
• Phone: +43 02732 90040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.