About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
Younger than 18 years old or older than 70 years old;
ECOG>1;
Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
Mutant type of driven genes;
Trial design
Parallel
Treatments tested in this trial
High-dose fractionated radiotherapy
RadiationPatients in this arm would receive high-dose fractionated radiotherapy with 60-68Gy/15-17f with one-year immunotherapy maintenance.
Low-dose fractionated radiotherapy
RadiationPatients in this arm would receive high-dose fractionated radiotherapy with 48Gy/15-12f with one-year immunotherapy maintenance.
Treatment groups
Trial outcomes
Primary outcomes
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Rate of radiation-induced pneumonitis (CTCAE V4.0)
Rate of radiation-induced esophagitis (CTCAE V4.0)
Rate of radiation-induced esophagitis (CTCAE V4.0)
Rate of myelosuppression (CTCAE V4.0)
Rate of myelosuppression (CTCAE V4.0)
Secondary outcomes
1 year locoregional control rate (RECIST 1.1)
1 year locoregional control rate (RECIST 1.1)
1 year progression-free rate (RECIST 1.1)
1 year progression-free rate (RECIST 1.1)
1 year overall survival rate (RECIST 1.1)
1 year overall survival rate (RECIST 1.1)
Sponsors and contacts
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