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A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor
The goal of this clinical trial is to compare the safety and efficacy (how well the drug works) of acasunlimab (also known as GEN1046) when it is used alone (monotherapy) versus when it is combined with a cancer drug (pembrolizumab) for participants with relapsed/refractory (disease has returned after treatment or did not respond to treatment) non-small cell lung cancer (NSCLC; the most common type of lung cancer). This trial has 2 parts. The purpose of the first part is to find out if the combination of acasunlimab and pembrolizumab is safe and to find out the best doses to use. The purpose of the second part is to give acasunlimab and pembrolizumab to more participants to evaluate efficacy. In the second part of the trial, participants will be randomized to participate in 1 of the 3 arms of the trial. Randomized means that the participant will be randomly assigned to a treatment arm based on chance; no one chooses their treatment arm. Participants will receive either acasunlimab alone (100 followed by 500 mg into the vein) or acasunlimab with pembrolizumab (200 or 400 mg into the vein) once every 3 or 6 weeks, depending on which arm the participant is randomized into. All participants will receive active drug; no one will receive placebo. Trial details include: * The average trial duration for an individual participant will be about 10 months. * The average treatment duration for an individual participant will be about 6 months. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Florida Cancer Specialists - FCS South
Fort Myers, Florida, United States
Florida Cancer Center
St. Petersburg, Florida, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan CHCWM P.C.
Grand Rapids, Michigan, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Institut Bergonie
Bordeaux, France
Hopital Morvan CHU de Brest
Brest, France
Hopital Charles Nicolle Chu Rouen
Rouen, France
Hopital dInstruction Des Armees Begin
Saint-Mandé, France
Start Date
October 27, 2021
Primary Completion Date
December 2, 2024
Completion Date
May 27, 2027
Last Updated
November 6, 2025
125
ACTUAL participants
Acasunlimab
BIOLOGICAL
Pembrolizumab
BIOLOGICAL
Lead Sponsor
Genmab
Collaborators
NCT03808662
NCT03907852
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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