Testing a new radiotherapy approach for non-small cell lung cancer
Official title: Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Run by The Netherlands Cancer Institute · NCT06528743 · Data updated 2026-11-12
This study is testing a new way of giving radiotherapy to see if it helps people with advanced non-small cell lung cancer feel better by using breaks in treatment to make the tumors more sensitive to the radiation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | August 8, 2024 |
| Main results expected | August 1, 2028 |
| Study ends | August 1, 2029 |
| Registry record updated | January 6, 2025 |
| Trial ID | NCT06528743 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with stage 2-4 non-small cell lung cancer referred for palliative radiotherapy.
✕Probably not a fit
Patients with interstitial lung disease or those who have received prior thoracic radiotherapy overlapping with the current treatment plan 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 study evaluates the safety and feasibility of a novel radiotherapy technique called primer shot fractionation for patients with non-small cell lung cancer (NSCLC). The approach involves administering an initial radiotherapy fraction followed by a treatment break to enhance tumor radiosensitivity through reoxygenation. The trial is designed as a prospective non-randomized feasibility study, utilizing a 3+3 phase design to assess increasing treatment breaks and includes an expansion cohort for further evaluation. Patients with stage 2-4 NSCLC who are referred for palliative radiotherapy will be included in the study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced non-small cell lung cancer by enhancing the effectiveness of radiotherapy.
How similar studies have gone: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * NSCLC (either pathology proven or sufficient clinical suspicion to be treated as NSCLC), referred for palliative radiotherapy of at least the primary tumor site. * Stage 2-4 * WHO performance score 0-2. * Provision of signed, written and dated IC prior to any study specific procedures. Exclusion Criteria: * Interstitial lung disease * Treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors * Prior thoracic radiotherapy (\>20 Gy EQD2 a/b 3) overlapping with the current planning target volume
Where it's running
-
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Amsterdam, Netherlands Recruiting
Study contacts
- Study coordinator: Zeno Gouw
- Email: z.gouw@nki.nl
- Phone: +31205129111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Therapeutic cancer vaccine for patients with advanced lung cancer resistant to immunotherapy
This study is testing a new cancer vaccine called OSE2101 to see if it can help people with advanced lung cancer who haven't responded to other immunotherapy treatments.
-
Omitting re-excision after complete primary melanoma excision
This trial tests whether people with pT1b–pT4b cutaneous melanoma whose tumors were completely removed can safely skip the usual re-excision surgery.
-
Living long-term with advanced GIST on tyrosine kinase inhibitors
This observational project will collect medical records and patient questionnaires to see how long-term tyrosine kinase inhibitor treatment affects quality of life and survivorship for adults with advanced or metastatic GIST who have taken TKIs for at least two years.
-
Ga68-PSMA PET/CT to tell radiation damage from tumor growth in brain metastases
This project will test whether a Ga68-PSMA PET/CT scan can tell radiation necrosis apart from tumor regrowth in adults with brain metastases from lung cancer, melanoma, or breast cancer.
-
Combining olaparib with cisplatin HIPEC during interval cytoreductive surgery for ovarian cancer
This study will test whether giving the PARP inhibitor olaparib around interval cytoreductive surgery with heated intraperitoneal cisplatin (HIPEC) is safe and feasible for adults with advanced high‑grade serous ovarian or fallopian tube cancer who responded to neoadjuvant chemotherapy.
-
Whole-body HER2 PET/CT to see how 89Zr-trastuzumab accumulates in HER2-positive or HER2-mutated advanced NSCLC
This study tests whether 89Zr-trastuzumab PET/CT can show how much tracer builds up in tumors of adults with HER2-positive or HER2-mutated advanced NSCLC.
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.