Clinical trial · Interventional
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer (PROMISE) - Phase I Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulse radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pulse Radiotherapy
- description
- Pulsed radiotherapy combined with PD(L)-1 inhibitors targeting 2 to 5 progressive extracranial lesions per cycle
- interventionNames
- Radiation: Pulse radiotherapy
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- Within 180 days of radiotherapy completion
- description
- Grade 3-5 toxicity as per Common Terminology Criteria for Adverse Events, version 4.0.
Secondary outcomes (4)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 2 years post radiotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available