Recruiting
Phase 1

Pulsed Radiotherapy & Immunotherapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06622174

Conditions

Non Small Cell Lung Cancer

Metastatic Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulse radiotherapy

Study Details

Brief summary:

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.

Conditions

Non Small Cell Lung Cancer

Metastatic Lung Cancer

Study ID

NCT06622174

Start date

Aug 20, 2026

Status verified date

Jul, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Radiological progression to ≥ 5 disease sites. Progression at the primary tumor site should be counted within the total number of progressive lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Patients with brain metastasis are allowed and should be treated as per standard of care
  • All sites of disease can, in the opinion of the investigator, be safely treated and targetable with high-to-intermediate or low dose radiotherapy (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
  • Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
  • Patients receiving additional systemic therapy agents such as chemotherapy are eligible, provided the other systemic agents are temporarily halted during radiation treatment.

Exclusion Criteria:

  • 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.
  • Presence of an active autoimmune disease.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulse Radiotherapy

Pulsed radiotherapy combined with PD(L)-1 inhibitors targeting 2 to 5 progressive extracranial lesions per cycle

Interventions

Pulse radiotherapy

Pulsed radiotherapy combined with PD(L)-1 inhibitors targeting 2 to 5 progressive extracranial lesions per cycle

Primary outcome measure

  • Toxicity [ Time Frame: Within 180 days of radiotherapy completion ]

Central Contacts and Locations

Central contacts

Houda Bahig, MD PhD

514-890-8254houda.bahig.med@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada

Contacts

Mom Phat

514-890-8254mom.phat.chum@ssss.gouv.qc.ca

Principal Investigator:

Houda Bahig, MD PhD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 24, 2026

Last verified

Jul, 2026

Keywords

  • Non small cell lung cancer
  • Metastatic lung cancer
  • Progressive disease
  • Polymetastatic
  • Immunotherapy resistance
  • Radiotherapy
  • Pulse radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-24.