Combining immune checkpoint inhibitors with radiotherapy for cancer treatment
Official title: Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
Run by University of Erlangen-Nürnberg Medical School · NCT04892849 · Data updated 2026-11-12
This study is testing if combining immune checkpoint inhibitors with radiotherapy can improve treatment for patients with certain types of cancer, like head and neck and lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Status | Recruiting |
| Started | April 30, 2021 |
| Main results expected | May 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT04892849 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with treatable HNSCC, NSCLC, or other solid tumors who are eligible for PD-1/PD-L1 inhibitor therapy.
✕Probably not a fit
Patients with melanoma or those unable to comply with the study protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the effectiveness of combining PD-1/PD-L1 immune checkpoint inhibitors with radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), and other solid tumors. The study aims to validate predictive biomarkers derived from previous trials to enhance treatment algorithms. Patients will receive conventional therapy according to clinical standards, and their immune responses will be monitored to assess the potential benefits of this combination approach.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced cancers by optimizing the use of immunotherapy and radiotherapy.
How similar studies have gone: Previous exploratory trials have shown promising results for similar combinations of immunotherapy and radiotherapy, indicating potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Melanoma patients * Fertile patients who refuse effective contraception during study treatment * Persistent drug and/or alcohol abuse * Patients not able or willing to behave according to study protocol * Patients in care * Patients that are not able to speak German * Patients which are imprisoned according to legal or governmental order Both gender are included into the study, a maximum age was not defined.
Where it's running
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Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany Recruiting
Study contacts
- Principal investigator: Udo S Gaipl, Prof. Dr. — Universitätsklinikum Erlangen, Department of Radiation Oncology
- Study coordinator: Markus Hecht, PD Dr.
- Email: markus.hecht@uk-erlangen.de
- Phone: +49 9131 85
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.