Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

Last updated: July 7, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pembrolizumab

Docetaxel

Acasunlimab

Clinical Study ID

NCT06635824
GCT1046-06
2024-512998-27-00
jRCT2051240178
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the metastatic setting.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has histologically or cytologically confirmed metastatic NSCLC (stage IVwith known subtype).

  • Participant has progressed radiographically on or after receiving:

  • One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapyconcomitantly) in the metastatic disease setting; OR

  • No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-basedchemotherapy sequentially, irrespective of the order) in the metastatic diseasesetting.

  • Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determinedprospectively on a tumor sample from the metastatic setting at a sponsor-designatedcentral laboratory.

  • Participant has measurable disease according to RECIST v1.1 as assessed by theinvestigator at baseline.

  • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.

  • Participant has a life expectancy of ≥3 months.

  • Participant must have adequate organ and bone marrow function, per laboratory testresults within 7 days of trial treatment.

Exclusion

Key Exclusion Criteria:

  • Documentation of known targetable epidermal growth factor receptor (EGFR)sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET),ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten ratsarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene;receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE:MET amplification testing is optional based on local availability of the test.

  • Participants with known KRAS/BRAF mutations are eligible for the trial if theydo not have access to approved targeted therapies.

  • Participants with newly identified or known unstable or symptomatic central nervoussystem (CNS) metastases or history of carcinomatous meningitis.

  • Prior treatment with docetaxel for NSCLC.

  • Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine,autologous cell immunotherapy, or any unapproved immunotherapy.

  • Treatment with an anticancer agent within 28 days prior to the first dose of trialtreatment.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Total Participants: 702
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
November 25, 2024
Estimated Completion Date:
October 31, 2029

Study Description

The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants must have:

  1. non-small cell lung cancer that has metastasized (spread)

  2. tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)

  3. been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially (irrespective of the order).

Other eligibility criteria will also apply.

Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows:

  • Acasunlimab (100 milligrams [mg]) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or

  • Docetaxel 75 milligrams per meter squared (mg/m^2) once every 3 weeks (Q3W).

The estimated trial duration for a participant will vary but may be up to 5 years, consisting of:

  • An optional 3-month pre-screening period

  • A 28-day screening period

  • Up to 2 years of treatment

  • A 90-day safety follow-up period

  • Post-treatment follow-up.

Connect with a study center

  • Centro de Investigacion Pergamino S.A.

    Pergamino, Buenos Aires
    Argentina

    Active - Recruiting

  • Instituto Medico Especializado Alexander Fleming

    Buenos Aires, Ciudad Autonoma Buenos Aires
    Argentina

    Active - Recruiting

  • Investigaciones CORI S.R.L.

    La Rioja,
    Argentina

    Active - Recruiting

  • Chris OBrien LifeHouse

    Camperdown, New South Wales
    Australia

    Active - Recruiting

  • Westmead Hospital

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • Gold Coast Hospital

    Southport, Queensland
    Australia

    Active - Recruiting

  • Sir Charles Gairdner Hospital

    Perth, Western Australia
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy,
    Australia

    Active - Recruiting

  • Ballarat Oncology & Haematology Service

    Wendouree,
    Australia

    Active - Recruiting

  • Kepler Universitatsklinikum Med Campus III

    Linz,
    Austria

    Active - Recruiting

  • LKH - Rankweil

    Rankweil,
    Austria

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels,
    Belgium

    Active - Recruiting

  • C. H. U. St-Pierre

    Bruxelles,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Bruxelles

    Bruxelles,
    Belgium

    Active - Recruiting

  • Grand Hôpital de Charleroi

    Gilly,
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis Hospital

    Hasselt,
    Belgium

    Active - Recruiting

  • AZ Sint-Maarten

    Mechelen,
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná
    Brazil

    Active - Recruiting

  • MultiHemo Servicos Medicos

    Recife, Pernambuco
    Brazil

    Active - Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Su
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Ijui

    Ijuí, Rio Grande do Sul
    Brazil

    Active - Recruiting

  • Centro Gaucho Integrado - Mae de Deus Center

    Porto Alegre, Rio Grande do Sul
    Brazil

    Active - Recruiting

  • Instituto D'Or Pesquisa e Ensino - Rio de Janeiro

    Rio de Janeiro, Rio do Janeiro
    Brazil

    Active - Recruiting

  • BP A Beneficencia Portuguesa de Sao Paulo

    São Paulo, Sao Paulo
    Brazil

    Active - Recruiting

  • Centro Paulista de Oncologia S.A.

    São Paulo, Sao Paulo
    Brazil

    Active - Recruiting

  • Hospital Sirio-Libanes

    São Paulo, Sao Paulo
    Brazil

    Active - Recruiting

  • Oncoclínicas do Brasil Serviços Médicos SA

    Belo Horizonte,
    Brazil

    Active - Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre,
    Brazil

    Active - Recruiting

  • Oncoclínicas Rio de Janeiro

    Rio de Janeiro,
    Brazil

    Active - Recruiting

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo Andre,
    Brazil

    Active - Recruiting

  • MHAT Heart and Brain - Pleven

    Pleven,
    Bulgaria

    Active - Recruiting

  • Complex Oncology Center - Plovdiv, EOOD

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • MHAT "Serdika", EOOD

    Sofia,
    Bulgaria

    Active - Recruiting

  • MHAT for women's health - Nadezhda, OOD

    Sofia,
    Bulgaria

    Active - Recruiting

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia,
    Bulgaria

    Active - Recruiting

  • UMHAT 'SofiaMed', OOD

    Sofia,
    Bulgaria

    Active - Recruiting

  • MUHC - Jewish General Hospital

    Montreal, Quebec
    Canada

    Active - Recruiting

  • FALP - Fundación Arturo López Pérez

    Providencia,
    Chile

    Active - Recruiting

  • Centro de Investigacion Clinica Bradford Hill

    Santiago,
    Chile

    Active - Recruiting

  • IRAM - Instituto de Radio Medicina

    Santiago,
    Chile

    Active - Recruiting

  • Oncocentro APYS

    Vina del Mar,
    Chile

    Active - Recruiting

  • General Hospital Dubrovnik

    Dubrovnik,
    Croatia

    Active - Recruiting

  • Specialty Hospital Medico

    Rijeka,
    Croatia

    Active - Recruiting

  • Sestre milosrdnice University Hospital Center

    Zagreb,
    Croatia

    Active - Recruiting

  • North Estonia Medical Centre Foundation

    Tallinn,
    Estonia

    Active - Recruiting

  • Tartu University Hospital

    Tartu,
    Estonia

    Active - Recruiting

  • Institut Bergonié

    Bordeaux cedex, Gironde
    France

    Active - Recruiting

  • Clinique Belharra

    Bayonne, Pyrenees Atlantiques
    France

    Active - Recruiting

  • Institut Sainte Catherine

    Avignon Cedex 9, Vaculuse
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif cedex, Val de Marne
    France

    Active - Recruiting

  • CHU Angers - Hôpital Larrey

    Angers,
    France

    Active - Recruiting

  • Centre Hospitalier de la côte Basque

    Bayonne,
    France

    Active - Recruiting

  • Hôpital Ambroise Paré

    Boulogne Billancourt,
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal de Creteil (CHIC)

    Creteil Cedex,
    France

    Active - Recruiting

  • Hopital Albert Calmette - CHU Lille

    Lille Cedex,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon Cedex,
    France

    Active - Recruiting

  • Assistance Publique-Hôpitaux de Marseille

    Marseille,
    France

    Active - Recruiting

  • CH de Mulhouse - Hôpital Emile Muller

    Mulhouse,
    France

    Active - Recruiting

  • Hôpital Privé du Confluent

    Nantes,
    France

    Active - Recruiting

  • Hopital Saint Joseph - Paris

    Paris,
    France

    Active - Recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • ICO - Site René Gauducheau

    Saint Herblain,
    France

    Active - Recruiting

  • Hôpital Sainte Musse

    Toulon,
    France

    Active - Recruiting

  • Alexandra General Hospital

    Athens,
    Greece

    Active - Recruiting

  • Henry Dunant Hospital Center

    Athens,
    Greece

    Active - Recruiting

  • University General Hospital Attikon

    Athens,
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion

    Heraklion,
    Greece

    Active - Recruiting

  • University General Hospital of Larissa

    Larissa,
    Greece

    Active - Recruiting

  • Bioclinic Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • Beaumont Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • St James's Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Milano
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Milano
    Italy

    Active - Recruiting

  • IRCCS Policlinico Universitario Agostino Gemelli

    Rome, Roma
    Italy

    Active - Recruiting

  • AOU San Luigi Gonzaga

    Orbassano, Torino
    Italy

    Active - Recruiting

  • Istituto di Candiolo

    Candiolo,
    Italy

    Active - Recruiting

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova,
    Italy

    Active - Recruiting

  • IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

    Meldola,
    Italy

    Active - Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna,
    Italy

    Active - Recruiting

  • Regina Elena National Cancer Institute

    Roma,
    Italy

    Active - Recruiting

  • CRC - Centro Ricerche Cliniche di Verona S.r.l.

    Verona,
    Italy

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama-shi, Ehime-Ken
    Japan

    Active - Recruiting

  • Hiroshima University Hospital

    Hiroshima-shi, Hiroshima-Ken
    Japan

    Active - Recruiting

  • Saiseikai Kumamoto Hospital

    Kumamoto-shi, Kumamoto-Ken
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osakasayama-shi, Osaka-Fu
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo-To
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku,
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku,
    Japan

    Active - Recruiting

  • NHO Kyushu Cancer Center

    Fukuoka-shi,
    Japan

    Active - Recruiting

  • NHO Hokkaido Cancer Center

    Hokkaido,
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto City,
    Japan

    Active - Recruiting

  • Kurashiki Central Hospital

    Kurashiki-shi,
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi,
    Japan

    Active - Recruiting

  • NHO Nagoya Medical Center

    Nagoya,
    Japan

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya-shi,
    Japan

    Active - Recruiting

  • Miyagi Cancer Center

    Natori-shi,
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka-shi,
    Japan

    Active - Recruiting

  • Gunma Prefectural Cancer Center

    Ota-shi,
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama-shi,
    Japan

    Active - Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Chungcheongbuk-do,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center Korea

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Amsterdam UMC Locatie VUMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

  • St. Jansdal Ziekenhuis

    Harderwijk,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Radboudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • Isala Zwolle

    Zwolle,
    Netherlands

    Active - Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow,
    Poland

    Active - Recruiting

  • Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)

    Lodz,
    Poland

    Active - Recruiting

  • Aidport sp z o.o.

    Skorzewo,
    Poland

    Active - Recruiting

  • Instytut Gruzlicy i Chorob Pluc w Warszawie

    Warszawa,
    Poland

    Active - Recruiting

  • Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano

    Matosinhos,
    Portugal

    Active - Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 917
    Puerto Rico

    Active - Recruiting

  • Pan American Oncology Trials, LLC

    San Juan, 902
    Puerto Rico

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba, Córdoba
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago CHUS

    Santiago de Compostela, La Coruña
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, Madrid
    Spain

    Active - Recruiting

  • H.C. Hospitales S.L.

    Marbella, Málaga
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • ICO Girona

    Girona,
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Quironsalud Malaga

    Malaga,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia,
    Spain

    Active - Recruiting

  • National Taiwan University Hospital Yunlin Branch

    Douliu,
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan City,
    Taiwan

    Active - Recruiting

  • Medical Park Seyhan Hospital

    Adana,
    Turkey

    Active - Recruiting

  • İ.E.Ü. Medicalpoint İzmir Hastanesi

    Izmir,
    Turkey

    Active - Recruiting

  • Barts Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals City Campus

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Derriford Hospital

    Plymouth,
    United Kingdom

    Active - Recruiting

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • Kaiser Permanente Vallejo Medical Center

    Vallejo, California 94589
    United States

    Active - Recruiting

  • Ocala Oncology Center P.L.

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • University Cancer & Blood Center, LLC

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • Piedmont Cancer Institute - Sandy Springs (Atlanta) Office

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Piedmont Cancer Institute Atlanta

    Atlanta, Georgia 30318
    United States

    Active - Recruiting

  • Piedmont Cancer Institute - Fayetteville Office

    Fayetteville, Georgia 30214
    United States

    Active - Recruiting

  • Piedmont Cancer Institute - Newnan Office

    Newnan, Georgia 30265
    United States

    Active - Recruiting

  • Piedmont Cancer Institute - Stockbridge Office

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Kaiser Foundation Hospitals

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Community Cancer Center East Medical Oncology Hematology

    Indianapolis, Indiana 46219
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Pikeville Medical Center

    Pikeville, Kentucky 41501
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • St. Francis Hospital - Grand Island

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Oncology Hematology West

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Parkridge Medical Center

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • University of Tennessee Medical Center Cancer Institute

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Midtown Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

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