A Phase 2 interventional study of Nivolumab 10 MG/ML Intravenous Solution and Relatlimab 10 MG/ML Intravenous Solution in NSCLC Stage II, NSCLC, Stage IIIA and NSCLC, Stage I, sponsored by University Hospital, Essen. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University Hospital, Essen · Phase 2, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 90 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nivolumab 2 cycles, every two weeks (q2w) o Nivolumab 240 mg i.v. over 30 min
Drug: Nivolumab 10 MG/ML Intravenous Solution
Nivolumab/Relatlimab (80 mg) 2 cycles, every two weeks (q2w) * Nivolumab 240 mg i.v. over 30 min * Relatlimab 80 mg i.v. over 30 min (within 30 min of nivolumab)
Drug: Nivolumab 10 MG/ML Intravenous Solution · Drug: Relatlimab 10 MG/ML Intravenous Solution
Nivolumab/Relatlimab (240 mg) 2 cycles, every two weeks (q2w) * Nivolumab 240 mg i.v. over 30 min * Relatlimab 240 mg i.v. over 30 min (within 30 min of nivolumab)
Drug: Nivolumab 10 MG/ML Intravenous Solution · Drug: Relatlimab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min
Feasibility of four weeks of preoperative immunotherapy with Nivolumab, Nivolumab plus Relatlimab (80 mg), and Nivolumab plus Relatlimab (240 mg)
Time frame: Within 43 days after first study medication
Estimation of pathological tumor response rate
Time frame: Within 43 days after first study medication (day of surgery)
Estimation of curative (R0) resection rate
Time frame: Within 43 days after first study medication (day of surgery)
Objective radiological response rate
Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Time frame: After 3, 6, 9 and 12 months post-surgery
Disease-free survival rate at 12 months
Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Time frame: 12 months
Overall survival rate at 12 months
Time frame: 12 months
Morbidity
Estimation of morbidity within 90 days after surgery
Time frame: within 90 days after surgery
Mortality
Estimation of mortality within 90 days after surgery
Time frame: within 90 days after surgery
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
University Hospital, Essen