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

Sponsor
University Hospital, Essen
Study ID
NCT04205552
Phase
PHASE2
Status
Completed

Conditions

  • NSCLC Stage II
  • NSCLC, Stage I
  • NSCLC, Stage IIIA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 4, 2020
Status verified
Jun 2026
Primary completion
Nov 27, 2025
Completion
Nov 27, 2025

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

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 ]

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