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

CompletedPhase 2

Sponsor: Anhui Provincial Hospital

Conditions: Non-Small Cell Lung Cancer

Interventions: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Hefei, Anhui, China