CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled / 90 target
Drug / intervention
Nivolumab 10 MG/ML Intravenous Solution +1 moredrug
Likely dose
Nivolumab 240 mg IV over 30 minutes every 2 weeks for 2 cycles; relatlimab 80 mg or 240 mg IV over 30 minutes (in combination arms) every 2 weeks for 2 cyclesAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed NSCLC eligible for curative surgical resection
  • ✓Clinical stage IB, II, or selected IIIA disease
  • ✓ECOG performance status 0 or 1
  • ✓Adequate pulmonary function for curative lung cancer surgery
Key exclusion· 16
  • ✕Active or prior autoimmune disease or immune deficiency
  • ✕Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days
  • ✕Prior organ transplant or allogeneic stem cell transplantation
  • ✕Uncontrolled or significant cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04205552
NCT04205552Phase 2CompletedOn Track (1.2/mo)Completion was 7mo ago
CompareCT.gov

Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response

University Hospital, Essen·interventional·Posted Dec 19, 2019·Updated Jun 11, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab 10 MG/ML Intravenous Solution and Relatlimab 10 MG/ML Intravenous Solution for NSCLC Stage II and 2 related conditions. Completed, enrolled 90 participants across 4 sites in 3 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC Stage II, NSCLC, Stage IIIA, NSCLC, Stage I
CountriesBelgium, Germany, Netherlands
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 19, 2019
Enrollment StartMar 4, 2020
Primary CompletionNov 27, 2025
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 6.5 years ago

Arms & Interventions

Nivolumabexperimental

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)experimental

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 SolutionDrug: Relatlimab 10 MG/ML Intravenous Solution
Nivolumab/Relatlimab (240 mg)experimental

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 SolutionDrug: Relatlimab 10 MG/ML Intravenous Solution

Interventions

Nivolumab 10 MG/ML Intravenous Solutiondrug

Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Relatlimab 10 MG/ML Intravenous Solutiondrug

Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min