Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
NCT ID: NCT05117242
Last Updated: 2025-11-06
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2021-10-27
2027-05-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles
Acasunlimab
Acasunlimab will be administered intravenously (IV)
Arm B
Treatment with acasunlimab + pembrolizumab once every 21 days
Acasunlimab
Acasunlimab will be administered intravenously (IV)
Pembrolizumab
Pembrolizumab will be administered IV
Arm C
Treatment with acasunlimab + pembrolizumab once every 42 days
Acasunlimab
Acasunlimab will be administered intravenously (IV)
Pembrolizumab
Pembrolizumab will be administered IV
Interventions
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Acasunlimab
Acasunlimab will be administered intravenously (IV)
Pembrolizumab
Pembrolizumab will be administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age.
* Have histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease
* Have a tumor PD-L1 expression result available prior to first treatment demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a central or local laboratory during screening.
* Have measurable disease per RECIST v1.1.
* Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
* Have life expectancy of at least 3 months.
* Have adequate organ and bone marrow function as defined in the protocol.
Exclusion Criteria
* Treatment with an anti-cancer agent within 28 days prior to acasunlimab administration.
* Any investigational agent (including investigational vaccines).
* Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions.
* Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone \>10 mg daily or a cumulative dose \>150 mg prednisone within 14 days before the first acasunlimab administration.
* Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
* Subject has contraindications to the use of pembrolizumab per local prescribing information.
* Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis (interstitial lung disease).
* Ongoing or active infection requiring intravenous treatment with anti-infective therapy or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
* Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia.
* Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management.
* Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
* Subject has a known history of any of the following:
1. Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment.
2. Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
3. Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis).
4. Organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab.
5. Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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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
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Gustave Roussy
Villejuif, , France
Med.Hochschule Hannover Klinik für Pneumologie
Hanover, , Germany
Universitatsklinik Giessen und Marburg Standort Giessen
Hessen, , Germany
LKI Lungenfachklinik Immenhausen
Immenhausen, , Germany
Department of Internal Medicine II
Regensburg, , Germany
Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco
Catania, , Italy
IRCCS Istituto Europeo di Oncologia
Milan, , Italy
UOC Oncoematologia AOU L.Vanvitelli
Napoli, , Italy
La Maddalena SPA
Palermo, , Italy
IFO Regina Elena
Roma, , Italy
Netherlands Cancer Institute
Amsterdam, , Netherlands
VU University Medical Center
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
Olsztyn, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, , Poland
Centro Clinico Champalimaud
Lisbon, , Portugal
Centro Hospitalar Universitário do Porto - Hospital de Santo Antonio
Porto, , Portugal
Hospital Universitari Vall dHebron
Barcelona, , Spain
Clinica Universidad de Navarra CUN
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Cheltenham General Hospital
Cheltenham, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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2021-001928-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1004314
Identifier Type: OTHER
Identifier Source: secondary_id
NL-OMON54259
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-513770-22-00
Identifier Type: OTHER
Identifier Source: secondary_id
RECF-005102
Identifier Type: REGISTRY
Identifier Source: secondary_id
15582
Identifier Type: REGISTRY
Identifier Source: secondary_id
GCT1046-04
Identifier Type: -
Identifier Source: org_study_id