Pulsed radiotherapy with immunotherapy for metastatic non-small cell lung cancer that stopped responding to prior treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm phase 1 trial will enroll up to 32 adults with polymetastatic NSCLC whose disease has progressed despite PD-(L)1 inhibitors. Participants will receive up to 3 cycles of pulsed radiotherapy targeting 2–5 progressing lesions per cycle, in combination with ongoing PD-(L)1 therapy (with or without chemotherapy). The primary goal is to assess treatment-related toxicity; secondary goals include progression-free survival, overall survival, and quality of life. The study explores whether pulsed radiotherapy can reduce tumor burden and potentially enhance the immune response in patients with resistance to immunotherapy. Eligible participants must have ECOG 0–2, measurable progression, and disease safely targetable with radiotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Houda Bahig, MD PhD
• Email: houda.bahig.med@ssss.gouv.qc.ca
• Phone: 514-890-8254

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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.