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Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer

ConditionsNon Small Cell Lung CancerMetastatic 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

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.

Houda Bahig

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Sponsor institution

Varian, a Siemens Healthineers Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: