Optimal combination of radiotherapy schedules and Benmelstobart to induce abscopal responses in metastatic NSCLC

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 a prospective, multicenter, phase 2 umbrella trial comparing different radiotherapy fractionation patterns combined with the immunotherapy agent Benmelstobart, often given alongside chemotherapy, to see which approach best controls untreated (abscopal) lesions. The primary objective is to compare control rates of abscopal lesions across the different radiotherapy schedules. Key eligibility includes pathologically confirmed NSCLC, more than three metastatic lesions, absence of actionable driver mutations, performance status 0–1, age 18–75, and no active brain metastases. Optional imaging such as PET-CT (FDG and FMISO) may be used for assessment and patients must have no contraindications to immunotherapy or radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must meet all of the following inclusion criteria to be enrolled in this study:

  1. Non-small cell lung cancer confirmed by pathological histology.
  2. More than 3 metastatic lesions.
  3. No brain metastases or stable lesions.
  4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
  5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
  6. Age between 18 and 75 years old.
  7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
  8. No contraindications to immunotherapy and radiotherapy.
  9. Signed the informed consent form.

Exclusion Criteria:

* Patients with any of the following criteria are not eligible for enrollment in this study:

  1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
  2. Those accompanied by other malignant tumors.
  3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
  4. Those with a history of mental illness.
  5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.

Where it's running

• the second affiliated hospital of Army medical university
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Principal investigator: Jianguo Sun, MD — the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting
• Study coordinator: Jianguo Sun, MD
• Email: sunjg09@aliyun.com
• Phone: 86-13983155736

Similar studies

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

• Finding the best organ-targeted radiotherapy plus chemo and PD-1 combinations to trigger abscopal responses in metastatic non-small cell lung cancer without EGFR/ALK mutations

  This study will try different combinations of radiotherapy, chemotherapy, and PD‑1 immunotherapy to see if they trigger whole-body (abscopal) tumor responses and improve outcomes for people with metastatic NSCLC who do not have EGFR or ALK mutations.

  Recruiting Phase 2 Xinqiao Hospital of Chongqing · Chongqing, Chongqing Municipality · NCT06947694

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.