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Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
NCT05117242 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Acasunlimab
Study Locations (20)
Other
- Institut Bergonie — Bordeaux
- Hopital Morvan CHU de Brest — Brest
- Hopital Charles Nicolle Chu Rouen — Rouen
- Hopital dInstruction Des Armees Begin — Saint-Mandé
- Institut de Cancerologie Strasbourg Europe (ICANS) — Strasbourg
- Hôpital Foch — Suresnes
- Gustave Roussy — Villejuif
- Med.Hochschule Hannover Klinik für Pneumologie — Hanover
- Universitatsklinik Giessen und Marburg Standort Giessen — Hessen
- LKI Lungenfachklinik Immenhausen — Immenhausen
- Department of Internal Medicine II — Regensburg
- Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco — Catania
- IRCCS Istituto Europeo di Oncologia — Milan
- UOC Oncoematologia AOU L.Vanvitelli — Naples
Florida
- Florida Cancer Specialists - FCS South — Fort Myers
- Florida Cancer Center — St. Petersburg
Michigan
- Henry Ford Cancer Institute — Detroit
- Cancer & Hematology Centers of Western Michigan CHCWM P.C. — Grand Rapids
California
- St. Joseph Heritage Healthcare — Santa Rosa
Wisconsin
- Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2027-05-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05117242
The ClinicalTrials.gov registry entry for NCT05117242 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non Small Cell Lung Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05117242 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05117242 about?
NCT05117242 is a clinical study titled "Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer". 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 aft...
What is the current status of trial NCT05117242?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2021-10-27. Estimated completion is 2027-05-27.
What conditions does trial NCT05117242 study?
This clinical trial studies the following conditions: Non Small Cell Lung Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05117242?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Acasunlimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05117242?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05117242 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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