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RECRUITING
NCT05269485
PHASE1/PHASE2

Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer

Sponsor: Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.

Official title: Hypofraction Radiotherapy Followed by Immune Checkpoint Inhibitors for Locally Advanced Non-small Cell Lung Cancer: A Phase I/II Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2021-08-01

Completion Date

2024-12-01

Last Updated

2024-06-25

Healthy Volunteers

Yes

Interventions

RADIATION

High-dose fractionated radiotherapy

Patients in this arm would receive high-dose fractionated radiotherapy with 60-68Gy/15-17f with one-year immunotherapy maintenance.

RADIATION

Low-dose fractionated radiotherapy

Patients in this arm would receive high-dose fractionated radiotherapy with 48Gy/15-12f with one-year immunotherapy maintenance.

Locations (1)

Anhui Provicial Hospital

Hefei, Anhui, China