NCT04432142|Active Not Recruiting
Immune Profiling of Stage III Non-small Cell Lung Cancer Patients Treated With Concurrent Chemoradiation and Adjuvant Durvalumab: A Prospective Observational Phase II Trial
IPON-1
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IPON-1
Sponsor study identifier
observational
45
1 country
1
Study Start
April 1, 2021
Actual (reported)Primary Completion
July 1, 2024
Actual (reported)Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 9, 2020
Actual (reported)June 16, 2020
Actual (reported)April 1, 2021
Actual (reported)July 1, 2024
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Immune changes
Number of patients with immune changes in stage III NSCLC patients receiving concurrent chemoradiation with protons or photons followed by durvalumab.
3 months
PFS
12 months
OS
12 months
Toxicity chemoradition
until 3 months after chemo/radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 during courses of Durvalumab
Until 12 months after chemo/radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Until 12 months after chemoradiation
Patients receiving proton therapy
Patients receiving photon therapy in 4 fractions or less
Patients with stage III NSCLC who are eligible for curative intent concurrent chemotherapy and radiotherapy will be enrolled in the study. They receive standard radiotherapy (60 Gy in 30 fractions of 2 Gy) with protons or photons according to the standard of care. Eligible patients will thereafter receive standard durvalumab immune therapy for 12 months. Eligibility criteria for this study are therefore similar to those for standard of care treatment.
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, 6229 ET, Netherlands
At five timepoints 60ml of blood will be drawn for biobanking of plasma, serum, and buffy coat samples.
Dirk De Ruysscher, MD, PhD
Maastro
45 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2020
First Posted
June 16, 2020
Study Start
April 1, 2021
Actual (reported)The Effects of an Nutritional Intervention on PD-1 ICI in NSCLC
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2024
Actual (reported)Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 27, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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