NCT04205552CompletedPhase 2
Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients
Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 16 Dec 2019
- Start date
- 4 Mar 2020
- Primary completion date
- 27 Nov 2025
- Lead sponsor
- University Hospital, Essen
- Diseases
- Lung cancer
- NCT number
- NCT04205552
- EU CT number
- 2024-513074-22-00
- EudraCT number
- 2019-002478-29
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 90
- From 4 Mar 2020 to the primary completion date, 27 Nov 2025
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
- Subjects who have undergone organ transplant or allogeneic stem cell transplantation
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication
- Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
- The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS) or implantation of a venous port-system.
- Any other concurrent preoperative antineoplastic treatment including irradiation
- Subjects with history of severe toxicity or life-threatening toxicity (grade 3 or 4) related to prior immune therapy
- Previous treatment with Nivolumab or Relatlimab
Other illness
- Active or history of autoimmune disease or immune deficiency
- Uncontrolled or significant cardiovascular disease
- Patients with active neurological disease
- Active malignancy or a prior malignancy within the past 3 years
- History of gastric perforation or fistulae in past 6 months
Lab values
- Prior treatment with Lymphocyte-activation gene 3 (LAG-3) targeting Agent
Other
- Peripheral polyneuropathy NCI CTCAE Grade ≥ 2
- Pregnant/Breastfeeding women
Who the study is looking for
- Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages I B, II and selected stage III A)
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Sufficient pulmonary function to undergo curative lung cancer surgery
- Adequate hematological, hepatic and renal function parameters:
- Sufficient cardiac left ventricular defined as left ventricular ejection fraction (LVEF) ≥ 50% documented either by echocardiography or multigated acquisition scan (MUGA)
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.