Actively Recruiting
Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer
Led by Karl Landsteiner University of Health Sciences · Updated on 2026-02-20
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The present study will explore a novel treatment strategy for unresectable lung adenocarcinoma combining a unique unconventional radiotherapy technique for high dose partial tumor irradiation (PTI) sparing the peritumoral immune microenvironment (PIM) with an immune checkpoint inhibitor (ICI)-based immunotherapy. The present study will focus on patients with larger, unresectable bulky lung tumors who previously failed standard of care therapy, or are unsuitable for conventional radio-chemotherapy due to tumor size and volume, and do not have any further therapeutic option left. This concept implies that a very high, ablative radiation dose (typically 20-25Gy per fraction) is delivered exclusively to the central bulky-tumor segment sparing at the same time surrounding PIM and therefore preserving its function. The present study will explore the potential clinical advantages of the above described innovative treatment concept as a rechallenge treatment: following the disease progression during initiated first-line ICI-therapy, or following discontinuation of ICI-therapy, a same previously used agent (ICI) will be added the PTI to boost its immunologic anti-tumor effects. The treatment response will be measured by comparing the progression-free survival 1 (PFS-1) (ICI-therapy alone) and progression-free survival 2 (PFS-2) (combined rechallange PTI-ICI) rates. The primary endpoint will be ∆PFS rate (PFS-2 vs PFS-1) assessed according to the modified iRECIST criteria. Secondary endpoints will include overall survival, toxicity, and exploration and validation of the anti-cancer immunity. Once treatment is completed, follow up will be performed on a regular basis (at 6 and 12 weeks, and every 3 months later on) by CT, MRT or PET-CT imaging to allow for endpoints assessment, or at any time in case of suspected disease progression. Patients will also be followed clinically with history and physical examinations, vital signs, and laboratory examinations as indicated.
CONDITIONS
Official Title
Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Biopsy confirmed unresectable lung adenocarcinoma
- Not eligible for surgery or conventional whole tumor radiotherapy
- Relapsed or refractory to any previous standard therapy including immune checkpoint inhibitors
- Age 18 years or older
- Female participants must be non-reproductive or use effective contraception with negative pregnancy test
- Willing and able to comply with follow-up visits and examinations
- Adequate immune blood counts: leucocytes 6000, neutrophils 1000
- PD-L1 expression of 1% or higher
You will not qualify if you...
- Resectable or curable lung cancer
- Tumors suitable for standard therapies including surgery or conventional radio-chemotherapy
- Lung cancer types other than adenocarcinoma
- Pregnant, breastfeeding, or reproductive potential without effective birth control
- Any condition interfering with treatment evaluation or safety assessment
- Uncontrolled seizures
- Inadequate immune blood counts: leucocytes below 4000, neutrophils below 1000
- PD-L1 expression below 1%
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radiation Oncology Department
Krems, Austria, Austria, 3500
Actively Recruiting
Research Team
S
Slavisa Tubin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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