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Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer

ConditionsNon Small Cell Lung CancerMetastatic Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Pulse radiotherapy

    Radiation

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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Pulse RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Toxicity

Grade 3-5 toxicity as per Common Terminology Criteria for Adverse Events, version 4.0.

Time frame
Within 180 days of radiotherapy completion

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from the start of adaptive pulse radiotherapy to the first documented disease progression or death from any cause.

Time frame
2 years post radiotherapy
2

Overall Survival (OS)

Time from the start of treatment to death from any cause.

Time frame
2 years post radiotherapy
3

Quality of Life (QoL)

Measured using validated patient-reported outcome questionnaires, such as the EORTC QLQ-C30, at baseline, during treatment, and every 6 months.

Time frame
until 2 years after radiotherapy
4

Long term toxicity

Grade 3-5 toxicity, based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
More than 180 days post-treatment up to 2 year post treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Varian, a Siemens Healthineers Company

Collaborator

Source ClinicalTrials.gov
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