Partial high-dose tumor irradiation combined with immunotherapy for unresectable lung adenocarcinoma
Rechallenge Using Combined Partial Tumor Irradiation and Immune Checkpoint Inhibitor-based Immunotherapy for Unresectable Lung Adenocarcinoma: a Pilot Study
This trial will try giving very high-dose radiation to the central part of large, unresectable lung adenocarcinomas while preserving the surrounding immune tissue and pairing that with an immune checkpoint drug for patients who have no remaining standard treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karl Landsteiner University of Health Sciences Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Krems, Austria) |
| Trial ID | NCT07423169 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with biopsy-proven unresectable bulky lung adenocarcinoma, PD-L1 ≥1%, adequate blood counts, who have failed or are ineligible for standard therapies and can attend treatment in Krems, Austria, are ideal candidates.
Not a fit: Patients with resectable disease, small tumors, PD-L1 <1%, significant immunosuppression, or those unable to tolerate high-dose radiation or immune therapy are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could control or shrink bulky tumors and stimulate systemic immune responses that extend disease control for patients without other options.
How similar studies have performed: Partial tumor irradiation alone has shown safety and immunostimulatory effects in earlier work, but combining PTI with immune checkpoint inhibitors in this setting has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Krems, Austria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.