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Immune profiling of stage III non-small cell lung cancer patients treated with concurrent chemoradiation and adjuvant durvalumab: A prospective observational phase II trial

Phase 2
Recruiting
Conditions
immune changes
non-small cell lung cancer
10038666
10029107
Registration Number
NL-OMON52550
Lead Sponsor
MAASTRO clinic
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
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:
o Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions
of 2 Gy) in patients with stage III NSCLC
o 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

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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