Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Greg Durm, MD
Study ID
NCT03285321
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.

Key Dates

Start date
Sep 15, 2017
Status verified
Dec 2025
Primary completion
Oct 13, 2023
Completion
Feb 6, 2024

Study Design

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

Arms

  • Experimental: Arm 1
    Nivolumab 480mg IV every 4 weeks for up to 6 cycles
  • Experimental: Arm 2
    Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab)

Primary Outcome Measure

Progression Free Survival (PFS) at 18-month [ Time Frame: 18 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
University of Illinois Cancer CenterChicagoIllinois60612-
Indiana UniversityIndianapolisIndiana46202-
University of Louisville James Graham Brown Cancer CenterLouisvilleKentucky40202-
Johns Hopkins Sidney Kimmel ComprehensiveBaltimoreMaryland21287-
Karmanos Cancer Center (Wayne State University)DetroitMichigan48201-
Michigan State UniversityLansingMichigan48910-
University of MinnesotaMinneapolisMinnesota55455-
University of Nebraska Medical CenterOmahaNebraska68198-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Penn State Cancer InstituteHersheyPennsylvania17033-
University of WisconsinMadisonWisconsin53705-

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