Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment34 (estimated)
SponsorThe Netherlands Cancer Institute
Academic / other
Locations1 site (Amsterdam)
StatusRecruiting
StartedAugust 8, 2024
Main results expectedAugust 1, 2028
Study endsAugust 1, 2029
Registry record updatedJanuary 6, 2025
Trial IDNCT06528743 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.