OncoMatch/Clinical Trials/NCT05229614
Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
Is NCT05229614 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Immunotherapy (Pembrolizumab) for non small cell lung cancer.
Treatment: Immunotherapy (Pembrolizumab) — Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response. Considering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Melanoma
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy — single agent
under treatment with single agent anti-PD1/PDL1 immunotherapy per clinical practice
Cannot have received: chemo-immunotherapy association
Patients treated with chemo-immunotherapy associations
Cannot have received: immunotherapy combination
Patients treated with immunotherapy combinations (e.g. subjects treated with anti-CTLA4 + anti-PD1/PDL1 are excluded)
Cannot have received: immunotherapy in clinical trial
Patients receiving immunotherapy within clinical trials
Cannot have received: off-label immunotherapy / expanded access / compassionate use
Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use
Cannot have received: radiation therapy
Previous RT, regardless of energy, on the metastatic site selected to be irradiated.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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