NCT04432142Active, 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
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 45 (actual)
- First submitted
- 9 Jun 2020
- Start date
- 1 Apr 2021
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Maastricht Radiation Oncology
- Diseases
- Lung cancer
- NCT number
- NCT04432142
What you commit to
- Study type: Observational
- Participants enrolled: 45
- From 1 Apr 2021 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer
Other illness
- Mixed non-small cell lung cancer with other histologies such as small cell lung 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht Radiation Oncology (MAASTRO clinic) Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.