RecruitingPhase 1Phase 2NCT05269485

Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer

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

Sponsor

Anhui Provincial Hospital

Enrollment

36 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Toxicity Due to Radiotherapy

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a shorter, more intensive radiation schedule (hypofractionation) for people with locally advanced non-small cell lung cancer (NSCLC) who cannot have surgery. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with stage III non-small cell lung cancer (NSCLC) - Your lung cancer does not have targetable driver gene mutations - Your cancer cannot be or you have declined surgery - You have a good performance status (ECOG 0–1) **You may NOT be eligible if...** - You are younger than 18 or older than 70 - Your tumor has a targetable mutation (e.g., EGFR, ALK) - You have small cell lung cancer or a neuroendocrine tumor - Your disease is not stage III (it has spread further or is earlier) - Your performance status is poor (ECOG above 1) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh-dose fractionated radiotherapy

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

RADIATIONLow-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

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NCT05269485

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