Higher-dose proton radiation for stage III non-small-cell lung cancer
Official title: Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
Run by University Medical Center Groningen · NCT06484491 · Data updated 2026-11-12
This pilot tests whether giving a higher dose of proton radiation together with chemo and planned immunotherapy is safe and tolerable for adults with stage III non-small-cell lung cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 87 (estimated) |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (Groningen) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | October 1, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT06484491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically proven stage III NSCLC, WHO performance status 0–2, planned for concurrent chemoradiation and adjuvant immunotherapy, and with most of the primary tumor located outside the mediastinal planning-risk volume are the intended candidates.
✕Probably not a fit
Patients whose primary tumor overlaps ≥40% with the mediastinal planning-risk volume, those not receiving concurrent chemotherapy or planned adjuvant immunotherapy, or those unable to complete follow-up assessments are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot enrolls adults with stage III non-small-cell lung cancer who will receive higher-dose intensity-modulated proton therapy (IMPT-74) together with standard chemotherapy and planned adjuvant durvalumab. Treatment includes induction chemotherapy (cisplatin or carboplatin plus pemetrexed), concurrent cisplatin plus docetaxel with escalated proton radiotherapy, and adjuvant durvalumab, with two extra clinic follow-ups and additional blood draws to monitor immune cells. The primary questions are whether severe radiotherapy toxicities requiring hospitalization remain within acceptable limits and to obtain a rough estimate of the treatment effect. Eligibility requires that the majority of the primary tumor volume lie outside the mediastinal planning-risk volume to allow safe dose escalation.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control without substantially increasing severe side effects, potentially improving outcomes for some patients.
How similar studies have gone: Proton therapy has shown promising toxicity profiles in lung cancer, but high-dose IMPT escalation combined with concurrent chemo and adjuvant immunotherapy remains relatively untested in definitive randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * WHO performance score 0-2 * Histologically proven stage III NSCLC * Planned for CCRT and adjuvant immunotherapy (intention to treat) * Primary tumour volume outside of mediastinal PRV (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation Exclusion Criteria: * Chemotherapy not given concurrently with radiotherapy * Upfront decision that adjuvant immunotherapy is not possible * Primary tumour overlapping ≥40% with mediastinal PRV * Unable or unwilling to understand the information on trial-related topics, to give informed consent or to fill out quality-of-life questionnaires
Where it's running
-
Umcg
Groningen, Netherlands Recruiting
Study contacts
- Principal investigator: R. Wijsman, MD PhD — University Medical Center Groningen
- Study coordinator: A. Hessels, MD PhD
- Email: a.c.hessels@umcg.nl
- Phone: 06-25648774
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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.