Actively Recruiting
Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients
Led by University Hospital, Essen · Updated on 2024-05-09
90
Participants Needed
4
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.
CONDITIONS
Official Title
Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages IB, II and selected stage IIIA)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Sufficient pulmonary function to undergo curative lung cancer surgery
- Adequate hematological, hepatic, and renal function parameters
- Sufficient cardiac left ventricular function defined as left ventricular ejection fraction (LVEF) of 50% or higher
- Patient able and willing to provide written informed consent and comply with study protocol and planned surgical procedures
You will not qualify if you...
- Active or history of autoimmune disease or immune deficiency
- Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
- History of organ transplant or allogeneic stem cell transplantation
- Uncontrolled or significant cardiovascular disease
- Active neurological disease
- Active malignancy or prior malignancy within the past 3 years
- Receipt of live attenuated vaccine within 30 days prior to first dose of study medication
- Peripheral polyneuropathy NCI CTCAE Grade 2 or higher
- History of gastric perforation or fistulae in past 6 months
- Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
- Major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS), or venous port-system implantation
- Any other concurrent preoperative antineoplastic treatment including irradiation
- Pregnant or breastfeeding women
- History of severe or life-threatening toxicity (grade 3 or 4) related to prior immune therapy
- Prior treatment with Lymphocyte-activation gene 3 (LAG-3) targeting agent
- Previous treatment with Nivolumab or Relatlimab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Jessa Hospital Hasselt
Hasselt, Belgium
Actively Recruiting
2
University Hospital Essen
Essen, Germany
Actively Recruiting
3
Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Actively Recruiting
4
Netherlands Cancer Institute
Amsterdam, Netherlands
Actively Recruiting
Research Team
C
Chiara Nicolini, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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