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 | Active Not Recruiting

• 1 other identifier: IPON-1
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• 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

Study Arms (2)

Proton

Patients receiving proton therapy

Photon

Patients receiving photon therapy in 4 fractions or less

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, 6229 ET, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

At five timepoints 60ml of blood will be drawn for biobanking of plasma, serum, and buffy coat samples.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk De Ruysscher, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)