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

Plain-language summary

This study examines hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors in patients with metastatic non-small cell lung cancer. It enrolled patients aged 18-75 without driver-gene mutations (such as EGFR, ALK, ROS1) who had a partial response or stable disease after first-line treatment. The study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Anhui Provincial Hospital

Intervention

Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors

Start date

3/1/2022

Estimated completion

5/1/2025

Countries

China

Related genes

Locations

• Hefei, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.