Status:
TERMINATED
Early Response Evaluation in NSCLC Patients Treated With Immunotherapy
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
NSCLC, Stage IV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FN...
Detailed Description
Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.
Eligibility Criteria
Inclusion
- willing and able to provide written informed consent for the study.
- ≥ 18 years of age on day of signing informed consent.
- confirmed diagnosis of NSCLC.
- Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
- Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
- Eligible and planned to receive nivolumab according to EMA label and national guidelines.
- Measurable disease according to RECIST v1.1.
- WHO performance status of 0-2.
Exclusion
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline PET-scan.
- Has an active infection or had an active infection within 2 weeks prior to baseline PET-scan.
- Has a known history of hypersensitivity to contrast material.
- Isolated distant relapse after curative intent treatment for stage I-III NSCLC.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04082988
Start Date
January 23 2018
End Date
May 22 2020
Last Update
October 10 2023
Active Locations (2)
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1
VU medical center
Amsterdam, Netherlands, 1007 MD
2
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA