Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHouda Bahig
About this trial
This phase I study aims to evaluate the safety and effectiveness of adaptive pulsed radiotherapy combined with immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) resistant to immune checkpoint inhibitors. The primary goal is to assess treatment-related toxicity, while secondary objectives include progression-free survival, overall survival, and quality of life. The study will enroll 32 patients.
Eligibility criteria
Qualifiers
Participants must be ≥ 18 years old
Ability to provide written informed consent
Actively receiving PD(L)-1 inhibitors
Progressive disease defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
Disqualifiers
Pregnant or breastfeeding individuals are excluded.
Medical conditions that would hinder the safe administration of radiotherapy or follow-up.
Patients who are ineligible for immunotherapy.
Patients with a history of pneumonitis are excluded.
Trial design
Treatments tested in this trial
- Pulse radiotherapy
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Houda Bahig
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor institution
Varian, a Siemens Healthineers Company
Collaborator
Source ClinicalTrials.gov