Status:
COMPLETED
Hybrid Dose-fraction Radiotherapy for Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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-sm...
Detailed Description
Trial Title: Hybrid dose-fraction Radiotherapy for metastatic driven-genes negative non-small cell lung cancer: A phase II multi-institutional study Trial Objective: To explore the safety and primary ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05348668
Start Date
March 1 2022
End Date
May 1 2025
Last Update
January 7 2026
Active Locations (1)
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1
Anhui Provicial Hospital
Hefei, Anhui, China