Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04205552

Studienbeginn:
März 2020

Letztes Update:
14.08.2023

Wirkstoff:
Nivolumab 10 MG/ML Intravenous Solution, Relatlimab 10 MG/ML Intravenous Solution

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienleiter

Martin Schuler, Prof. Dr.
Principal Investigator
University Hospital, Essen

Kontakt

Chiara Nicolini, PhD
Kontakt:
Phone: 0049 201 723 44708
E-Mail: chiara.nicolini@uk-essen.de» Kontaktdaten anzeigen

Studienlocations
(3 von 4)

University Hospital Essen
Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Jessa Hospital Hasselt
Hasselt
BelgiumRekrutierend» Google-Maps

Netherlands Cancer Institute
Amsterdam
NetherlandsRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)

Secondary outcome:

1. Estimation of pathological tumor response rate (Time Frame - Within 43 days after first study medication (day of surgery))

2. Estimation of curative (R0) resection rate (Time Frame - Within 43 days after first study medication (day of surgery))

3. Objective radiological response rate (Time Frame - After 3, 6, 9 and 12 months post-surgery):
Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

4. Disease-free survival rate at 12 months (Time Frame - 12 months):
Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

5. Overall survival rate at 12 months (Time Frame - 12 months)

6. Morbidity (Time Frame - within 90 days after surgery):
Estimation of morbidity within 90 days after surgery

7. Mortality (Time Frame - within 90 days after surgery):
Estimation of mortality within 90 days after surgery

Studien-Arme

Experimental: Nivolumab
Nivolumab 2 cycles, every two weeks (q2w) o Nivolumab 240 mg i.v. over 30 min
Experimental: Nivolumab/Relatlimab (80 mg)
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)
Experimental: Nivolumab/Relatlimab (240 mg)
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)

Geprüfte Regime

Nivolumab 10 MG/ML Intravenous Solution:
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
Relatlimab 10 MG/ML Intravenous Solution:
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min

Quelle: ClinicalTrials.gov

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