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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Joseph Heritage Healthcare — Santa Rosa, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
- St. Joseph Heritage Healthcare — Santa Rosa, California
- Florida Cancer Specialists - FCS South — Fort Myers, Florida
- Florida Cancer Center — St. Petersburg, Florida
- Henry Ford Cancer Institute — Detroit, Michigan
- Cancer & Hematology Centers of Western Michigan CHCWM P.C. — Grand Rapids, Michigan
- Medical College of Wisconsin — Milwaukee, Wisconsin
- 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,
- La Maddalena SPA — Palermo,
- IFO Regina Elena — Roma,
- Netherlands Cancer Institute — Amsterdam,
- VU University Medical Center — Amsterdam,
- Leids Universitair Medisch Centrum — Leiden,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.