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Immune Profiling of Stage III Non-small Cell Lung Cancer Patients Treated With Concurrent Chemoradiation and Adjuvant Durvalumab: A Prospective Observational Phase II Trial
MinorCompletion date: Dec 1, 2025 to Dec 1, 2026v7
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 80 to confirmed 45 · Primary completion date changed from estimate of Apr 1, 2024 to Jul 1, 2024 · Completion date: Apr 1, 2024 to Dec 1, 2025 · 1 morev6Show 4 more changesShow less
Enrollment target: estimated 80 to confirmed 45
Primary completion date changed from estimate of Apr 1, 2024 to Jul 1, 2024
Completion date: Apr 1, 2024 to Dec 1, 2025
Site details revised
NotablePrimary completion date: Apr 1, 2023 to Apr 1, 2024v5
MinorRe-verified, no change to tracked fieldsv4
NotableTrial status: Not Yet Recruiting to RecruitingSite details revisedv3Show 1 more changeShow less
Site details revised
NotableStart date: Sep 1, 2020 to Apr 1, 2021Primary completion date: Sep 1, 2023 to Apr 1, 2023 · Completion date: Sep 1, 2024 to Apr 1, 2024 · Study title expanded, about 5 wordsv2Show 3 more changesShow less
Primary completion date: Sep 1, 2023 to Apr 1, 2023
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Currently, there is only limited data available on the functional immune changes after concurrent chemoradiation in NSCLC (non-small cell lung cancer) patients. Identifying the effect of the treatment on immune cells and what their functional consequences are is an essential first step to come to prognostic and predictive biomarkers.
Many studies investigating the role of immunomodulatory effects of treatment are carried out in either in vitro or in vivo animal models. However, identified factors frequently hamper clinical validation. In addition, as mentioned earlier, although several immunogenic factors have been shown to be released by irradiated tumor cells, so far, only a limited number of studies searched for potential predictive and prognostic immunological biomarkers.
This will be the first time that the immune effects of both treatment modalities will be studied, with, in addition, the immune changes during durvalumab treatment, which are also unknown at present. By getting more insight in the treatment-induced immunomodulatory effects, ultimately, in subsequent projects, this will allow to determine optimal immune stimulation and hence improved outcomes of subsequent durvalumab immune therapy.