Personalized PULSAR radiotherapy for advanced small cell lung cancer and brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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.

Cohort C:

* \>=18 years old
* Performance status ECOG 0-2
* Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures \>5 cm in any direction as assessed by imaging
* Eligible to receive immunotherapy

Cohort D:

* \>=18 years old
* Performance status ECOG 0-2
* Pathologically proven diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
* Clinical stage III/IVA (AJCC 8th edition)
* Disease must be deemed resectable by head and neck surgeon
* Eligible to receive immunotherapy

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

Cohort C:

* Unresectable or metastatic (nodal or distant) disease
* Synchronous malignancy requiring chemotherapy or other intensive treatment
* Locally recurrent soft tissue sarcoma
* Prior immunotherapy
* Pregnancy or breastfeeding

Cohort D:

* Distant metastasis
* Inability to undergo PET-CT for baseline staging
* HPV-positive or p16-positive oropharyngeal cancer
* Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
* Prior immunotherapy for the study cancer or for a remote cancer
* Prior head and neck radiotherapy

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• Preventing heart problems in overweight/obese young sarcoma survivors with tirzepatide

  This feasibility study tests whether tirzepatide can be safely given to overweight or obese young adults (18–39) who have completed doxorubicin for soft tissue or bone sarcoma to see if it’s feasible to use in the first year after therapy.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07874828

• HMPL-A830 in solid tumors for adults with unresectable or metastatic cancer

  This first-in-human study tests HMPL-A830 in adults with unresectable or metastatic solid tumors to see how safe it is and how it behaves at varying doses.

  Recruiting at 4 sites Phase 1/2 Hutchmed · Orange, California and 13 other locations · NCT07718581

• LUCINAE Registry: Thoracic Cancers in Pregnancy

  This international registry collects data to see how thoracic cancers, including lung cancer, are managed and what outcomes look like for pregnant people and their babies.

  Recruiting at 4 sites Oncology Institute of Southern Switzerland · Baden and 3 other locations · NCT07699861

• Heart-friendly medicines to protect chest-area cancer patients from radiation damage

  This Phase 2 trial tests whether taking atorvastatin and lisinopril can reduce heart damage in adults with chest-area cancers who receive radiation therapy.

  Recruiting Phase 2 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07685938

• Imaging with 89Zr-DFO-YS5 to detect cancer

  This study tests a new PET radiotracer, 89Zr-DFO-YS5, to see if it can show cancer sites in adults with nerve sheath tumors, bladder cancer, or other solid tumors.

  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT07664397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.