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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04205552
Other study ID # CA224-063
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 4, 2020
Est. completion date June 2025

Study information

Verified date May 2024
Source University Hospital, Essen
Contact Chiara Nicolini, PhD
Phone 0049 201 723 44708
Email chiara.nicolini@uk-essen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Belgium Jessa Hospital Hasselt Hasselt
Germany University Hospital Essen Essen
Germany Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg Heidelberg
Netherlands Netherlands Cancer Institute Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Essen

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

References & Publications (1)

Schuler 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 wi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Estimation of pathological tumor response rate Within 43 days after first study medication (day of surgery)
Secondary Estimation of curative (R0) resection rate Within 43 days after first study medication (day of surgery)
Secondary Objective radiological response rate Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 After 3, 6, 9 and 12 months post-surgery
Secondary Disease-free survival rate at 12 months Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 12 months
Secondary Overall survival rate at 12 months 12 months
Secondary Morbidity Estimation of morbidity within 90 days after surgery within 90 days after surgery
Secondary Mortality Estimation of mortality within 90 days after surgery within 90 days after surgery
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