Status:
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
Lead Sponsor:
Maastricht Radiation Oncology
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
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...
Detailed Description
Even with the addition of durvalumab to concurrent chemoradiation, approximately only half of the patients are alive at 3 years, and more have progressed already, either locally or distant. Not much i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04432142
Start Date
April 1 2021
End Date
December 1 2025
Last Update
November 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands, 6229 ET