Personalized PULSAR radiotherapy for advanced small cell lung cancer and brain metastases
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types
This trial will try personalized PULSAR radiotherapy schedules to see if they are safe and helpful for adults with extensive-stage small cell lung cancer who need thoracic radiation and for adults with 1–5 brain metastases.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | atezolizumab, durvalumab, ipilimumab, nivolumab, chemotherapy, radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07139990 on ClinicalTrials.gov |
What this trial studies
This Phase 1 effort uses PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy) to adapt standard thoracic and brain radiation schedules to individual patient responses. Cohort A enrolls adults with extensive-stage small cell lung cancer receiving standard chemoimmunotherapy to test thoracic PULSAR consolidation, while Cohort B enrolls adults with 1–5 MRI-defined brain metastases to test focal PULSAR treatment of those lesions. The protocol focuses on feasibility, safety, and preliminary signals of efficacy with close toxicity monitoring and standardized imaging follow-up. Treatments and assessments are delivered at UT Southwestern with protocol-specified dose and fractionation adjustments based on early response.
Who should consider this trial
Good fit: Ideal candidates are adults with extensive-stage SCLC planned for thoracic radiotherapy during or after standard chemoimmunotherapy (≤3 cycles received, ECOG 0–2) or adults with 1–5 MRI-defined brain metastases that meet the trial's size criteria.
Not a fit: Patients with prior thoracic radiotherapy, prior whole-brain radiotherapy or prior focal treatment of a target brain lesion, leptomeningeal disease, poor performance status, or those unable to attend the Dallas treatment site are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, personalized PULSAR radiotherapy could shorten treatment time, maintain or improve tumor control, and reduce side effects compared with standard schedules.
How similar studies have performed: Prior trials showed modest survival gains from adding PD-L1 inhibitors to chemotherapy and mixed signals for consolidative thoracic RT (CREST vs RTOG 0937), with some preliminary safety data for hypofractionated RT plus PD-1 therapy, so the PULSAR personalized approach is relatively novel in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort A: * \>=18 years old * Performance status ECOG 0-2 * Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration. * Patient must be planned for or receiving standard of care chemoimmunotherapy. * Patient must have received no more than 3 cycles by time of study enrollment. * Able and indicated according to investigator to receive thoracic radiotherapy Cohort B: * 18 years old * Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration * Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size. Exclusion Criteria: Cohort A: ⨀ Prior thoracic Radiotherapy Cohort B: * Prior whole brain Radiotherapy * Prior surgical resection or focal radiotherapy of a target brain metastasis * Leptomeningeal disease
Where this trial is running
Dallas, Texas
- Ut Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Neil Desai, Md, Mhs — University of Texas Southwestern Medical Center
- Study coordinator: Sarah Neufeld
- Email: Sarah.Hardee@UTSouthwestern.edu
- Phone: 214 648 1836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.