Exploration of whole-brain radiotherapy with PD-1 inhibitors for brain injury in SCLC

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 is an observational study enrolling adults with limited- or extensive-stage small cell lung cancer who meet PCI indications after initial treatment. The plan compares a cohort receiving first-line chemo plus immunotherapy with PCI for those who respond to initial therapy to a control cohort receiving standard chemoradiotherapy with PCI. After two cycles of treatment, patients with a confirmed response may proceed to PCI. The study aims to observe outcomes without randomizing participants to treatment arms. Lead site is the Affiliated Hospital of GuiZhou Medical University, with Guizhou Medical University as sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer, and meeting the indications for prophylactic cranial irradiation (PCI): patients with limited-stage disease achieving complete response (CR) or partial response (PR) after first-line treatment; patients with extensive-stage disease achieving effective tumor control after systemic therapy, with no clear evidence of brain metastasis.
2. Age 18-75 years, Karnofsky Performance Status (KPS) score ≥ 70.
3. Estimated survival ≥ 6 months, with completion of at least 12 months of follow-up.
4. No contraindications to radiotherapy, chemotherapy, or immunotherapy.
5. Good compliance with the treatment protocol and follow-up, and provision of informed consent.

Exclusion Criteria:

1. Patients with brain metastases, cerebral infarction, cerebral hemorrhage, sequelae of traumatic brain injury, or other primary brain diseases (e.g., Alzheimer's disease, multiple sclerosis) confirmed by MRI before enrollment.
2. Patients who have previously received brain radiotherapy, brain surgery, or immunotherapy.
3. Patients with psychiatric disorders or cognitive impairment (MMSE score \< 26) unable to cooperate with follow-up assessments.
4. Patients with a history of other malignancies prior to or concurrent with the current treatment.
5. Severe cardiac, pulmonary, or renal disease, active autoimmune disease, or uncontrolled active infectious disease.
6. Pregnant or lactating women.

Where it's running

• the Affiliated Hospital of GuiZhou Medical University
  Guiyang, Guizhou, China Recruiting

Similar studies

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

• Multiomic analysis in relapsed small-cell lung cancer with DLL3 T cell engager

  This observational study tests how blood and tumor markers change over time in adults with relapsed small-cell lung cancer who are receiving a DLL3-targeted therapy, to see if those changes relate to clinical outcomes.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07795411

• 68Ga-YQ-CC05: a new probe for detecting tumors with CCK2R

  This study tests a radioactive probe called 68Ga-YQ-CC05 to see if it can safely help find tumors in adults with certain cancers using PET-CT imaging.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07914764

• Informational Needs of Caregivers of Patients in Neuro Rehab: Validating the QBI-R/V

  This study tests a caregiver questionnaire (QBI-R and QBI-V) to see how well it measures caregivers’ informational needs during neuromotor rehabilitation.

  Recruiting at 13 sites Istituti Clinici Scientifici Maugeri SpA · Sciacca, Agrigento and 12 other locations · NCT07903298

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

  This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886047

• IDP-121 plus chemotherapy in platinum-resistant small cell lung cancer

  This trial tests higher and higher doses of IDP-121 with chemotherapy to see if it is safe and workable for adults with advanced small cell lung cancer that progressed after first-line platinum therapy.

  Recruiting at 6 sites Phase 1/2 IDP Discovery Pharma S.L. · Barcelona and 9 other locations · NCT07864207

• Armored DLL3-SAVVYZ-IL18 CAR T cells for DLL3+ cancers

  Aims to see if DLL3-SAVVYZ-IL18 CAR T cells can be safely given to people with DLL3-positive cancers, including certain small cell lung cancers and other neuroendocrine tumors.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07783477

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.