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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-04

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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NSCLC Stage II NSCLC, Stage IIIA NSCLC, Stage I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivolumab

Nivolumab 2 cycles, every two weeks (q2w)

o Nivolumab 240 mg i.v. over 30 min

Group Type EXPERIMENTAL

Nivolumab 10 MG/ML Intravenous Solution

Intervention Type DRUG

Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

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)

Group Type EXPERIMENTAL

Nivolumab 10 MG/ML Intravenous Solution

Intervention Type DRUG

Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Relatlimab 10 MG/ML Intravenous Solution

Intervention Type DRUG

Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min

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)

Group Type EXPERIMENTAL

Nivolumab 10 MG/ML Intravenous Solution

Intervention Type DRUG

Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Relatlimab 10 MG/ML Intravenous Solution

Intervention Type DRUG

Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min

Interventions

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Nivolumab 10 MG/ML Intravenous Solution

Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Intervention Type DRUG

Relatlimab 10 MG/ML Intravenous Solution

Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No