RecruitingPhase 2NCT04205552

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


Sponsor

University Hospital, Essen

Enrollment

90 participants

Start Date

Mar 4, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing nivolumab (an immunotherapy drug) given before surgery in combination with other treatments for patients with resectable non-small cell lung cancer (NSCLC), to see if it can shrink the cancer before removal and improve long-term outcomes. **You may be eligible if...** - You have non-small cell lung cancer confirmed by biopsy that can be surgically removed (clinical stage IB, II, or selected stage IIIA) - Your general health is good (ECOG 0–1) - Your lung function is adequate for surgery - Your blood counts, liver, and kidney function are within acceptable ranges - Your heart pumping function is at least 50% **You may NOT be eligible if...** - You have an active autoimmune disease or immune deficiency - You have a condition requiring chronic steroid or immunosuppressive therapy - Your lung cancer cannot be safely removed surgically Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 10 MG/ML Intravenous Solution

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


Locations(4)

Jessa Hospital Hasselt

Hasselt, Belgium

University Hospital Essen

Essen, Germany

Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg

Heidelberg, Germany

Netherlands Cancer Institute

Amsterdam, Netherlands

View Full Details on ClinicalTrials.gov

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NCT04205552


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