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Clinical Trials in the Netherlands / NCT04432142
Active, not recruiting Observational

Immune Profiling of Stage III Non-small Cell Lung Cancer Patients Treated With Concurrent Chemoradiation and Adjuvant Durvalumab: A Prospective Observational Phase II Trial

NCT04432142 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Maastricht Radiation Oncology
Phase
Observational
Started
2021-04-01
Last updated
2026-01-27

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC * Participant is willing and able to give informed consent for participation in the trial * Male or female, aged 18 years or above * Scheduled to receive one of the following two therapeutic strategies: * Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) in patients with stage III NSCLC * Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) in patients with stage III NSCLC * Is able and willing to comply with all trial requirement Exclusion Criteria: * Mixed non-small cell lung cancer with other histologies such as small cell lung cancer * Not able to comply with the study protocol * Less than 18 years' old * Pregnancy or not able to comply with adequate contraception in women with child baring potential * Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer * Previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened) * Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maastricht Radiation Oncology (MAASTRO clinic) Maastricht Netherlands

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Other trials for the same condition

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) Recruiting
Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC Active, not recruiting
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1. Recruiting
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers Recruiting
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04432142 on ClinicalTrials.gov ↗ ← All trials in the Netherlands