NCT05348668CompletedPhase 2
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 · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 21 Apr 2022
- Start date
- 9 May 2022
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05348668
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 78
- From 9 May 2022 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- First-line treatment of other therapy rather than ICI±chemotherapy;
- Contraindications for radiotherapy, chemotherapy and ICI;
Other illness
- Small-cell lung cancer and other neuroendocrine carcinoma;
Lab values
- Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;
Age
- younger than 18 years old or older than 75 years old;
Other
- ECOG\>1;
- Non stage IV confirmed by radiological examination;
- Complete response (CR) or progression (PD) after first-line treatment;
- No signature of inform consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provicial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.