Trials Sponsors Conditions Drugs Pricing

Brief Summary

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

Bulky Tumors Lung Adenocarcinoma Unresectable Cancer

Keywords

Partial IrradiationImmunomodulationRadio-Vaccine

Outcome Measures

Primary Outcomes (1)

∆Progression-Free Survival (PFS) rate (PFS-2 vs PFS-1)
∆Progression-Free Survival (PFS) rate measured as a time-difference (in months) between the survival free from tumor progression at local and distant site of initial ICI treatment (PFS-1) and rechallenge PTI-ICI (PFS-2).
From radiotherapy treatment to the end of follow up period at 12 months

Secondary Outcomes (5)

Overall survival
From radiotherapy treatment until the date of death from any cause assessed up to 12 months
Toxicity: presence of any treatment-related adverse events/side effects
From radiotherapy treatment initiation to the end of follow up period at 12 months
Validation of the anti-cancer immunity by the absolute counts of peripheral blood mononuclear cells (PBMC)
From radiotherapy treatment to the end of follow up period at 12 months
Validation of the anti-cancer immunity by the absolute counts of surface marker expression
From radiotherapy treatment to the end of follow up period at 12 months
Validation of the anti-cancer immunity by the concentration (pg/mL or IU/mL) of immunoregulatory cytokines
From radiotherapy treatment to the end of follow up period at 12 months

Study Arms (1)

Unresectable, bulky lung adenocarcinoma

EXPERIMENTAL

Radiation: Partial Tumor Irradiation

Interventions

Partial Tumor IrradiationRadiation

A very high, ablative radiation dose of 20-25Gy will be delivered exclusively to the central bulky-tumor segment sparing at the same time surrounding Peritumoral Immune Microenvironment and therefore preserving its function. Partial Tumor Irradiation is going to be delivered as a single fraction (1 day-treatment).

Unresectable, bulky lung adenocarcinoma

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent
Biopsy proven unresectable lung adenocarcinoma

Sponsors & Collaborators

Karl Landsteiner University of Health Sciences
Otherlead

Study Sites (1)

Radiation Oncology Department

Krems, Austria, 3500, Austria

RECRUITING

Slavisa Tubin, MDCONTACT+43 02732 90040 slavisa.tubin@krems.lknoe.at

Slavisa Tubin, MDPRINCIPAL INVESTIGATOR

Peter Errhalt, Prim. Clin. Ass. Prof.SUB INVESTIGATOR

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Officials

Slavisa Tubin, MD
University Clinic Krems, Radiation Oncology Department
PRINCIPAL INVESTIGATOR

Central Study Contacts

Slavisa Tubin, MD

CONTACT

+43 02732 90040 slavisa.tubin@krems.lknoe.at

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 20, 2026

Study Start

February 2, 2026

Actual (reported)

Primary Completion

February 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Unresectable, bulky lung adenocarcinoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Unresectable, bulky lung adenocarcinoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations