Targeted high- and low-dose radiation with chemotherapy and immunotherapy for advanced lung cancer

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

Adults with advanced lung cancer who progressed on prior immunotherapy are randomized 1:1 to an experimental arm receiving spatially fractionated radiation to a single lesion (high-dose region 800–1200 cGy ×3 fractions, low-dose regions 100–300 cGy ×5 fractions) plus low‑dose irradiation to other metastatic sites together with chemotherapy and immunotherapy, or to a control arm receiving conventional radiotherapy followed by chemo‑immunotherapy. Radiotherapy and systemic therapy are given during or within one week after radiotherapy, with serial blood immune monitoring and tumor biopsies taken before radiotherapy and after one cycle of immunotherapy to assess immune microenvironment changes. The trial records detailed toxicity and safety data and measures clinical efficacy outcomes in this phase II design. The aim is to see if the combined spatially fractionated and low‑dose radiation approach improves response and favorably alters immune markers compared with standard radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign the informed consent form.
2. Be at least 18 years old.
3. Have a Karnofsky Performance Status (KPS) score of 70 or higher and an expected survival of more than 3 months.
4. Have histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma.
5. Have received prior immunotherapy and experienced disease progression.
6. The site targeted for radiotherapy has not been previously irradiated or it has been at least 6 months since the last radiotherapy.

Exclusion Criteria:

1. The patient has lesions that are not suitable for radiotherapy: malignant pleural effusion, ascites, meningeal metastasis, etc.
2. The patient has other serious comorbidities, such as myocardial infarction occurring within 6 months, severe arrhythmia, mental illness, etc., is unable to complete the treatment, or has an expected survival period of less than 3 months.
3. The patient has severe organ dysfunction, such as liver failure, cardiopulmonary failure, etc., and is difficult to tolerate radiotherapy.
4. The patient currently has a severe infection.
5. The patient has a known or suspected active autoimmune disease (congenital or acquired), such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Patients with vitiligo or those with cured childhood asthma can be included; patients with type 1 diabetes who have good insulin control can also be included).
6. The patient has experienced grade 3 or above cardiac or liver toxicity reactions or grade 4 toxicity reactions in other organs during previous immunotherapy.
7. Other situations where reviewers consider there are sufficient reasons for disqualification from the registered study: such as potential situations inconsistent with the clinical protocol.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Ningbo Liu, doctor
• Email: liuningbo@tjmuch.com
• Phone: +86 15602036608

Similar studies

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

• Shape-sensing robotic bronchoscopy to diagnose peripheral lung nodules

  This tests a shape-sensing robotic bronchoscopy to see if it can get tissue samples from adults in Korea with peripheral lung nodules.

  Recruiting Ulsan University Hospital · Ulsan · NCT07057648

• AVZO-1418 alone and with other treatments for advanced epithelial solid tumors

  This trial will test whether intravenous AVZO-1418, alone or with other cancer drugs, is safe and helps adults with locally advanced or metastatic epithelial solid tumors, including some lung cancers.

  Recruiting at 27 sites Phase 1/2 Avenzo Therapeutics, Inc. · Gilbert, Arizona and 26 other locations · NCT07038343

• Online and in-person exercise programs for cancer survivors in Canada

  This study is testing whether online and in-person exercise programs can help cancer survivors in Canada stay active and improve their health.

  Recruiting at 5 sites University of Calgary · Calgary, Alberta and 4 other locations · NCT06960291

• General anesthesia versus conscious sedation for radial endobronchial ultrasound

  This trial will see if general anesthesia or conscious sedation gives better diagnostic results for adults undergoing radial endobronchial ultrasound to sample peripheral lung nodules.

  Recruiting at 2 sites Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec and 3 other locations · NCT06950515

• Super1 TCR-T for NY-ESO-1–positive advanced solid tumors

  This trial tests whether a single infusion of Super1 TCR-T can help people with advanced sarcoma, lung cancer, or melanoma whose tumors are HLA-A*02 positive and express NY-ESO-1.

  Recruiting Phase 1 Guangzhou FineImmune Biotechnology Co., LTD. · Guangzhou, Gaungdong · NCT06942143

• Using a new molecular probe for early diagnosis of tumors

  This study is testing a new imaging tool to see if it can help doctors find different types of tumors earlier in patients aged 18 to 75 who already have confirmed tumor lesions.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT06937112

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.