Partial Tumor Irradiation and Immunotherapy for Unresectable Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarl Landsteiner University of Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Biopsy proven unresectable lung adenocarcinoma
Ineligibility for surgery and conventional curative (whole tumor) radiotherapy, and relapsed/refractory to any previous standard of care therapy including ICI
Age ≥ 18 years,
Disqualifiers
Patients with resectable/curable lung cancer
Tumors suitable for the standard of care therapies including surgery or conventional curative (whole tumor) radio-chemotherapy
Lung cancer histology other than adenocarcinoma
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
Trial design
Design model
Single group
Treatments tested in this trial
Partial Tumor Irradiation
RadiationA 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).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Unresectable, bulky lung adenocarcinomaExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
From radiotherapy treatment to the end of follow up period at 12 monthsSecondary outcomes
1
Overall survival
Calculated as the time (in months) from treatment initiation to death.
Time frame
From radiotherapy treatment until the date of death from any cause assessed up to 12 months2
Toxicity: presence of any treatment-related adverse events/side effects
Number of Participants With Treatment-Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame
From radiotherapy treatment initiation to the end of follow up period at 12 months3
Validation of the anti-cancer immunity by the absolute counts of peripheral blood mononuclear cells (PBMC)
Measures the absolute counts of peripheral blood mononuclear cells (PBMC)
Time frame
From radiotherapy treatment to the end of follow up period at 12 months4
Validation of the anti-cancer immunity by the absolute counts of surface marker expression
Measures the absolute counts of surface marker expression (CD markers) of the CD4+ T Cells, CD8+ T Cells, CD19+ B Cells, CD14+ Monocytes
Time frame
From radiotherapy treatment to the end of follow up period at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov