Blood immune markers in cancer patients treated with immunotherapy and radiotherapy
Observes immune cells in blood of adults with NSCLC, HNSCC and other cancers.
Plain-language title generated from the registry record
Registry title: Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
Key facts
- Where
- Erlangen, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a PD-1/PD-L1 inhibitor drug for head and neck, lung or another solid tumour. They may or may not have had radiotherapy to metastases.
- Age
- At least 18 years; no maximum age.
- Sex
- All sexes can join.
- Disease stage
- Head and neck squamous cell cancer (palliative), non-small cell lung cancer (palliative or adjuvant), or another solid tumour.
- Earlier treatment
- Radiotherapy to one or more metastases is allowed but not required. Standard-of-care PD-1/PD-L1 inhibitor treatment must be planned.
Main reasons for not taking part
- Melanoma
- Fertile patients who refuse effective contraception during treatment
- Ongoing drug or alcohol abuse
- Cannot speak German
- Imprisoned by legal or governmental order
Read by machine on 9 November 2026.
Where in Germany
- Department of Radiation Oncology, Universitätsklinikum ErlangenErlangen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Erlangen-Nürnberg Medical School
- Trial code
- NCT04892849
- Record updated
- 17 September 2025
- Original description
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effectsRead full original descriptionShow less
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects
Inclusion: Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or "other solid tumour"; Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards; Patients without or with radiation of one or more metastases; Age at least 18 years.
Exclusion: Persistent drug and/or alcohol abuse; Patients which are imprisoned according to legal or governmental order; Both gender are included into the study, a maximum age was not defined; Melanoma patients; Fertile patients who refuse effective contraception during study treatment; Patients not able or willing to behave according to study protocol; Patients in care; Patients that are not able to speak German.