NSCLC Stage II, NSCLC, Stage IIIA, NSCLC, Stage I
Conditions
Brief 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.
Interventions
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
DRUGRelatlimab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min
Sponsors
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of four weeks of preoperative immunotherapy with Nivolumab, Nivolumab plus Relatlimab (80 mg), and Nivolumab plus Relatlimab (240 mg) | Within 43 days after first study medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of curative (R0) resection rate | Within 43 days after first study medication (day of surgery) | — |
| Objective radiological response rate | After 3, 6, 9 and 12 months post-surgery | Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 |
| Disease-free survival rate at 12 months | 12 months | Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 |
| Estimation of pathological tumor response rate | Within 43 days after first study medication (day of surgery) | — |
| Morbidity | within 90 days after surgery | Estimation of morbidity within 90 days after surgery |
| Mortality | within 90 days after surgery | Estimation of mortality within 90 days after surgery |
| Overall survival rate at 12 months | 12 months | — |
Countries
Belgium, Germany, Netherlands
Contacts
Primary ContactChiara Nicolini, PhD
Outcome results
None listed