Clinical trial · Interventional
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
NCT04205552CI-TRIAL-00114457NEOpredictcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC, Stage IIIA | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab 10 MG/ML Intravenous Solution | Drug | Nivolumab | ALIAS |
| Relatlimab 10 MG/ML Intravenous Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Nivolumab
- description
- Nivolumab 2 cycles, every two weeks (q2w) o Nivolumab 240 mg i.v. over 30 min
- interventionNames
- Drug: Nivolumab 10 MG/ML Intravenous Solution
- type
- EXPERIMENTAL
- label
- Nivolumab/Relatlimab (80 mg)
- description
- 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)
- interventionNames
- Drug: Nivolumab 10 MG/ML Intravenous Solution
- Drug: Relatlimab 10 MG/ML Intravenous Solution
- type
- EXPERIMENTAL
- label
- Nivolumab/Relatlimab (240 mg)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Active or history of autoimmune disease or immune deficiency * 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 * Uncontrolled or significant cardiovascular disease * Patients with active neurological disease * Active malignancy or a prior malignancy within the past 3 years * Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication * Peripheral polyneuropathy NCI CTCAE Grade ≥ 2 * 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. * 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 * Pregnant/Breastfeeding women * Subjects with history of severe toxicity 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
References
Publications (1)
- RESULTSchuler M, Cuppens K, Plones T, Wiesweg M, Du Pont B, Hegedus B, Koster J, Mairinger F, Darwiche K, Paschen A, Maes B, Vanbockrijck M, Lahnemann D, Zhao F, Hautzel H, Theegarten D, Hartemink K, Reis H, Baas P, Schramm A, Aigner C. Neoadjuvant nivolumab with or without relatlimab in resectable non-small-cell lung cancer: a randomized phase 2 trial. Nat Med. 2024 Jun;30(6):1602-1611. doi: 10.1038/s41591-024-02965-0. Epub 2024 Apr 30. PMID 38689060