Combining low-dose and conventional radiotherapy for lung cancer after immunotherapy resistance

A Clinical Study on Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Non Small Cell Lung Cancer After Immunotherapy Resistance

This study is testing if combining low-dose and regular radiation therapy can help people with non-small cell lung cancer who haven't responded to immunotherapy feel better and live longer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Drugs / interventions: radiation, chemotherapy, immunotherapy
• Locations: 1 site (Jinan, In Shandong Province)
• Trial ID: NCT05906329 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of combining low-dose radiotherapy with conventional fractionated radiotherapy in patients with non-small cell lung cancer who have developed resistance to immunotherapy. The study aims to evaluate various outcomes, including the objective response rate, progression-free survival, disease control rate, health-related quality of life, and the incidence of adverse events. Patients will receive targeted radiotherapy based on enhanced imaging, and the treatment will be administered alongside their existing immunotherapy regimen. The trial is designed as a single-arm, open-label study conducted at a specialized hospital.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with non-small cell lung cancer who have shown resistance to prior immunotherapy and have no standard treatment options available.

Not a fit: Patients with severe allergies, significant comorbidities, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for lung cancer patients who have exhausted standard therapies after immunotherapy resistance.

How similar studies have performed: While the combination of radiotherapy and immunotherapy has been explored in other studies, this specific approach targeting immunotherapy-resistant lung cancer is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 1. Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.

  2. Age range from 18 to 65 years old, regardless of gender.

  3. ECOG level 0-1; Expected life\>6 months.

  4. At least get into a liquid diet.

  5. No history of severe allergies.

  6. Hemoglobin ≥ 100 g/L, WBC ≥ 3.5 x10\~9/L, neutrophils ≥ 1.8 x10\~9/L, platelets ≥ 10 x10\~9/L; AST and ALT ≤ 2.5 × normal upper limit, AKP ≤ 2.5 × normal upper limit.

  7. Non small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma) confirmed by cytology or histology.

  8. Complete clinical data.

  9. ≤ 10 primary and regional metastatic lymph nodes and distant metastatic lesions, and ≤ 5 organ metastases.

  10. Malignant tumor patients with immune therapy resistance (evaluated after 6-8 weeks of treatment and no improvement in clinical symptoms) without standard treatment options.

  11. There are measurable primary lesions, regional lymph node metastasis, and distant metastatic lesions.

Exclusion Criteria:

* 1. Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).

  2. Refusal or lack of cooperation in research.

  3. Patients who have participated in other clinical studies/trials within three months.

  4. Patients with brain metastases.

  5. The researcher determines that there are any patients who are not suitable to participate in the study.

  6. Accompanied by severe infections.

  7. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease or chronic system diseases such as uncontrollable diabetes and hypertension; Patients who cannot tolerate radiation therapy.

  8. Previous occurrence of immune related toxic side effects (immune myocarditis, pneumonia, etc.).

  9. Previous history of radiation therapy.

Where this trial is running

Jinan, In Shandong Province

• The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)16766 Jingshi Road, Jinan City — Jinan, In Shandong Province, China (RECRUITING)

Study contacts

• Principal investigator: Pingping Hu, Dr. — Deputy chief physician
• Study coordinator: Jiandong Zhang, Dr.

Conditions: Cancer Patients, lung cancer, radiotherapy, immunotherapy resistance