Clinical trial · Interventional
Hybrid Dose-fraction Radiotherapy for Metastatic Non-small Cell Lung Cancer
Hybrid Dose-fraction Radiotherapy for Metastatic Driven-genes Negative Non-small Cell Lung Cancer: A Phase II Multi-institutional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hybrid dose-fraction Radiotherapy Arm
- description
- Patients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors.
- interventionNames
- Drug: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 1-year
- description
- Progression-free Survival evaluated by RECIST (v1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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