Higher-dose proton radiation for stage III non-small-cell lung cancer
Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06484491 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Groningen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.