Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer

NCT06622174 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PROMISE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Toxicity

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

  Within 180 days of radiotherapy completion

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  2 years post radiotherapy

• Overall Survival (OS)

  2 years post radiotherapy

• Quality of Life (QoL)

  until 2 years after radiotherapy

• Long term toxicity

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

Study Arms (1)

Pulse Radiotherapy

EXPERIMENTAL

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

Radiation: Pulse radiotherapy

Interventions

Pulse radiotherapy RADIATION

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

Pulse Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Houda Bahig: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Houda Bahig, MD PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist, MD PhD

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: October 2, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

CA (1)