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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 18-70 years old;

• Eastern Cooperative Oncology Group (ECOG) 0-1;

• Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma;

• Wild-type of driven genes;

• Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT);

• Surgically unresectable or deny of surgery;

• Signature of inform consent.

Locations
Other Locations
China
Anhui Provicial Hospital
RECRUITING
Hefei
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 36
Treatments
Experimental: High-dose hypofraction Arm
Irradiation of 60-68Gy/15-17f is administered followed by one-year immunotherapy maintenance.
Experimental: Low-dose hypofraction Arm
Irradiation of 48Gy/12f is administered followed by one-year immunotherapy maintenance.
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov

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