Hybrid Dose-fraction Radiotherapy for Metastatic Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anhui Provincial Hospital
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

• 18-75 years old;

• Eastern Cooperative Oncology Group (ECOG) 0-1;

• Non-small cell lung cancer, including squamous-cell carcinoma, adenocarcinoma, large-cell carcinoma, adenosquamous carcinoma;

• Stage IVA and IVB confirmed by radiological examination (AJCC 8th Edition);

• Driven-genes negative including EGFR (Epidermal Growth Factor Receptor), ALK (Anaplastic Lymphoma Kinase), ROS1 (ROS Proto-Oncogene 1), KRAS G12C (Kirsten Rat Sarcoma Viral Oncogene), BRAF V600E (v-raf murine sarcoma viral oncogene homolog B1), MET exon14 (Mesenchymal Epithelial Transition Factor), RET (Rearranged during Transfection Proto-oncogene), NTRK1/2/3 (NeuroTrophin Receptor Kinase);

• First-line treatment of ICI±chemotherapy;

• Partial response (PR) or stable (SD) after first-line treatment;

• Signature of inform consent.

Exclusion Criteria:

• younger than 18 years old or older than 75 years old;

• ECOG>1;

• Small-cell lung cancer and other neuroendocrine carcinoma;

• Non stage IV confirmed by radiological examination;

• Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;

• First-line treatment of other therapy rather than ICI±chemotherapy;

• Complete response (CR) or progression (PD) after first-line treatment;

• Contraindications for radiotherapy, chemotherapy and ICI;

• No signature of inform consent.