PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLCPhase 3NCT06635824
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
A Phase 3 study testing Acasunlimab, Pembrolizumab and Docetaxel in people with PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, run by Genmab at 247 sites in 27 countries.
Trial 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 locally advanced (unresectable stage IIIB/C) or programmed death ligand 1 (PD-L1)-positive metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
- What is being tested?
- Acasunlimab, Pembrolizumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 247 sitesin 27 countries
- Study dates
- 25 Nov 2024to 30 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or metastatic NSCLC (stage IV) with known subtype.
- Participant has progressed radiographically on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting.
- Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the locally advanced (unresectable stage IIIB/C) or metastatic setting at a sponsor-designated central laboratory.
- Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
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- 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 test results within 7 days of trial treatment.
Who cannot join
- 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 rat sarcoma 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 they do not have access to targeted therapies.
- Participants with newly identified, untreated or unstable or symptomatic central nervous system (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 trial treatment.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
247 sites in 27 countries.
247 sites in 27 countries
United States36 sites
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Piedmont Cancer Institute Atlanta
Atlanta, Georgia, 30318
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
Atlanta, Georgia, 30328
Texas Oncology-Austin Midtown
Austin, Texas, 78705
Texas Oncology-Austin Central
Austin, Texas, 78731
South Austin Cancer Ctr
Austin, Texas, 78745
Novant Health Pharmacy
Charlotte, North Carolina, 28204
University of Virginia Hematology and Oncology
Charlottesville, Virginia, 22903
Parkridge Medical Center
Chattanooga, Tennessee, 37404
University of Illinois
Chicago, Illinois, 60612
Piedmont Cancer Institute - Fayetteville Office
Fayetteville, Georgia, 30214
St. Francis Hospital - Grand Island
Grand Island, Nebraska, 68803
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96817
Community Cancer Center East Medical Oncology Hematology
Indianapolis, Indiana, 46219
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, 37920
Baptist Health Lexington
Lexington, Kentucky, 40503
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Norton Cancer Institute
Louisville, Kentucky, 40202
Midtown Tennessee Oncology
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37205
Piedmont Cancer Institute - Newnan Office
Newnan, Georgia, 30265
Ocala Oncology Center P.L.
Ocala, Florida, 34474
Oncology Hematology West
Omaha, Nebraska, 68124
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Pikeville Medical Center
Pikeville, Kentucky, 41501
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Cancer Institute At Swedish Med Ctr
Seattle, Washington, 98104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Washington University School of Medicine
St Louis, Missouri, 63110
Piedmont Cancer Institute - Stockbridge Office
Stockbridge, Georgia, 30281
Stony Brook University Medical Center|University Medical Center
Stony Brook, New York, 11790
Arizona Blood and Cancer Specialists
Tucson, Arizona, 85712
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Japan22 sites
Juntendo University Hospital
Bunkyō City, Tokyo-To
Nippon Medical School Hospital
Bunkyō City
National Cancer Center Hospital
Chūōku
NHO Kyushu Cancer Center
Fukuoka
Hiroshima University Hospital
Hiroshima, Hiroshima
NHO Hokkaido Cancer Center
Hokkaido
JCHO Kyushu Hospital
Kitakyushu-shi, Fukuoka
Kobe Minimally Invasive Cancer Center
Kobe, Hyōgo
Cancer Institute Hospital of JFCR
Kōtō City
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto
Kurashiki Central Hospital
Kurashiki-shi
Kurume University Hospital
Kurume-shi
Shikoku Cancer Center
Matsuyama, Ehime
Aichi Cancer Center Hospital
Nagoya
NHO Nagoya Medical Center
Nagoya
Miyagi Cancer Center
Natori-shi
Okayama University Hospital
Okayama
Osaka International Cancer Institute
Osaka
Osaka Medical and Pharmaceutical University Hospital
Osaka
Kindai University Hospital
Osakasayama-shi, Osaka
Gunma Prefectural Cancer Center
Ota-shi
Kanagawa Cancer Center
Yokohama
Spain20 sites
Hospital General Universitario Dr. Balmis
Alicante
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba, Córdoba
ICO Girona
Girona
ICO l'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Las Palmas
Facility name: Clínica Universidad de Navarra
Madrid
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario HM Sanchinarro
Madrid
Hospital Quironsalud Malaga
Málaga
Hospital Universitario Virgen de la Victoria
Málaga
H.C. Hospitales S.L.
Marbella, Málaga
Clinica Universidad de Navarra
Pamplona, Navarre
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid
Complejo Hospitalario Universitario de Santiago CHUS
Santiago de Compostela, La Coruña
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Universitari i Politecnic La Fe
Valencia
IVO - Instituto Valenciano de Oncologia
Valencia
France19 sites
CHU Angers - Hôpital Larrey
Angers
Institut Sainte Catherine
Avignon, Vaculuse
Clinique Belharra
Bayonne, Pyrenees Atlantiques
Centre Hospitalier de la côte Basque
Bayonne
Institut Bergonié
Bordeaux, Gironde
Hôpital Ambroise Paré
Boulogne-Billancourt
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil
Hopital Albert Calmette - CHU Lille
Lille
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône
Assistance Publique-Hôpitaux de Marseille
Marseille
CH de Mulhouse - Hôpital Emile Muller
Mulhouse
Hôpital Privé du Confluent
Nantes
Hopital Saint Joseph - Paris
Paris
Institut Curie
Paris
CHU Rennes - Hopital Pontchaillou
Rennes
ICO - Site René Gauducheau
Saint-Herblain
Hôpital Sainte Musse
Toulon
Institut Gustave Roussy
Villejuif, Val De Marne
Brazil14 sites
Oncoclínicas do Brasil Serviços Médicos SA
Belo Horizonte
Hospital Erasto Gaertner
Curitiba, Paraná
Hospital de Clinicas de Ijui
Ijuí, Rio Grande do Sul
Clínica de Neoplasias Litoral Ltda.
Itajaí, Santa Catarina
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, Rio Grande do Sul
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande Do Su
Hospital Ernesto Dornelles
Porto Alegre
MultiHemo Servicos Medicos
Recife, Pernambuco
Instituto D'Or Pesquisa e Ensino - Rio de Janeiro
Rio de Janeiro, Rio Do Janeiro
Oncoclínicas Rio de Janeiro
Rio de Janeiro
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André
BP A Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo
Centro Paulista de Oncologia S.A.
São Paulo, São Paulo
Hospital Sirio-Libanes
São Paulo, São Paulo
Italy14 sites
IRCCS Centro di Riferimento Oncologico
Aviano, Pordenone
ASST Papa Giovanni XXIII
Bergamo
Istituto di Candiolo
Candiolo
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola
IRCCS Istituto Nazionale dei Tumori
Milan
Fondazione IRCCS San Gerardo dei Tintori
Monza, Milano
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Napoli
AOU San Luigi Gonzaga
Orbassano, Torino
Ospedale Santa Maria delle Croci
Ravenna
Regina Elena National Cancer Institute
Roma
IRCCS Policlinico Universitario Agostino Gemelli
Rome, Roma
Istituto Clinico Humanitas
Rozzano, Milano
CRC - Centro Ricerche Cliniche di Verona S.r.l.
Verona
Germany13 sites
Evangelische Lungenklinik Berlin
Berlin
Vivantes Klinikum im Friedrichshain
Berlin
Vivantes Klinikum Neukoelln
Berlin
Vivantes Klinikum Spandau
Berlin
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Saxony
Klinikum Esslingen GmbH
Esslingen am Neckar, Baden-Wurttemberg
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony
LungenClinic Grosshansdorf GmbH
Großhansdorf, Schleswig-Holstein
MVZ Martha-Maria Halle-Doelau
Halle, Saxony-Anhalt
Asklepios Klinik Harburg
Hamburg
MHH Medizinische Hochschule Hannover
Hanover, Lower Saxony
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg
Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate
Netherlands9 sites
Amsterdam UMC Locatie VUMC
Amsterdam
Antoni van Leeuwenhoek
Amsterdam
St. Jansdal Ziekenhuis
Harderwijk
Zuyderland Medisch Centrum - Heerlen
Heerlen
Leiden University Medical Center
Leiden
Radboudumc
Nijmegen
Erasmus Medisch Centrum
Rotterdam
Universitair Medisch Centrum Utrecht
Utrecht
Isala Zwolle
Zwolle
Turkey (Türkiye)9 sites
Adana City Hospital
Adana
Medical Park Seyhan Hospital
Adana
Ankara City Hospital
Ankara
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara
Gulhane Training and Research Hospital
Ankara
Liv Hospital Ankara
Ankara
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul
İ.E.Ü. Medicalpoint İzmir Hastanesi
Izmir
Australia8 sites
Flinders Medical Centre
Bedford Park, South Australia
Chris OBrien LifeHouse
Camperdown, New South Wales
St Vincent's Hospital Melbourne
Fitzroy
Sir Charles Gairdner Hospital
Perth, Western Australia
Gold Coast Hospital
Southport, Queensland
St John of God Subiaco Hospital
Subiaco, Western Australia
Westmead Hospital
Sydney, New South Wales
Ballarat Oncology & Haematology Service
Wendouree
Belgium8 sites
C. H. U. St-Pierre
Brussels
Cliniques Universitaires Saint-Luc
Brussels
Universitair Ziekenhuis Bruxelles
Brussels
Grand Hôpital de Charleroi
Gilly
Jessa Ziekenhuis Hospital
Hasselt
CHU de Liège
Liège
AZ Sint-Maarten
Mechelen
AZ Delta
Roeselare
Greece7 sites
Alexandra General Hospital
Athens
Henry Dunant Hospital Center
Athens
University General Hospital Attikon
Athens
University General Hospital of Heraklion
Heraklion
University General Hospital of Larissa
Larissa
Bioclinic Thessaloniki
Thessaloniki
Interbalkan Hospital of Thessaloniki
Thessaloniki
South Korea7 sites
Chungbuk National University Hospital
Cheongju-si
Keimyung University Dongsan Hospital
Daegu
National Cancer Center Korea
Goyang-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Ajou University Hospital
Suwon, Gyeonggi-do
Argentina6 sites
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Ciudad Autonoma Buenos Aires
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires
Hospital Italiano de La Plata
La Plata, Buenos Aires
Investigaciones CORI S.R.L.
La Rioja
Centro de Investigacion Pergamino S.A.
Pergamino, Buenos Aires
Sanatorio Parque S.A.
Rosario, Santa Fe Province
Bulgaria6 sites
MHAT Heart and Brain - Pleven
Pleven
Complex Oncology Center - Plovdiv, EOOD
Plovdiv
MHAT "Serdika", EOOD
Sofia
MHAT for women's health - Nadezhda, OOD
Sofia
UMHAT "Sv. Ivan Rilski", EAD
Sofia
UMHAT 'SofiaMed', OOD
Sofia
Ireland6 sites
Cork University Hospital
Cork
Beaumont Hospital
Dublin
St James's Hospital
Dublin
St Vincent's University Hospital
Dublin
University Hospital Limerick
Limerick
Waterford Regional Hospital
Waterford
Poland6 sites
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
Koszalin
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow
Polish Mother's Memorial Hospital (Instytut Centrum Zdrowia Matki Polki)
Lodz
Aidport sp z o.o.
Skorzewo
Instytut Gruzlicy i Chorob Pluc w Warszawie
Warsaw
Maria Sklodowska-Curie National Research Institute of Oncology (Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie)
Warsaw
United Kingdom6 sites
Beatson West of Scotland Cancer Care
Glasgow, Strathclyde
Barts Hospital
London
Guy's Hospital
London
The Christie Hospital
Manchester
Nottingham University Hospitals City Campus
Nottingham
Derriford Hospital
Plymouth
Taiwan5 sites
National Taiwan University Hospital Yunlin Branch
Douliu
National Cheng Kung University Hospital
Tainan
National Taiwan University Cancer Center
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital,Linkou
Taoyuan City
Austria4 sites
Kepler Universitatsklinikum Med Campus III
Linz
LKH - Rankweil
Rankweil
Standort Penzing der Klinik Ottakring
Vienna
Wiener Gesundheitsverbund - Klinik Floridsdorf
Vienna
Canada4 sites
William Osler Health System-Brampton Civic Hospital|William Osler Health System
Brampton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario
MUHC - Jewish General Hospital
Montreal, Quebec
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario
Chile4 sites
FALP - Fundación Arturo López Pérez
Providencia
Centro de Investigacion Clinica Bradford Hill
Santiago
IRAM - Instituto de Radio Medicina
Santiago
Oncocentro APYS
Viña del Mar
Croatia4 sites
General Hospital Dubrovnik
Dubrovnik
Specialty Hospital Medico
Rijeka
Department for Pulmonary Diseases University Hospital Centre Zagreb
Zagreb
Sestre milosrdnice University Hospital Center
Zagreb
Portugal4 sites
Unidade Local de Saude de Coimbra E P E
Coimbra
Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
Matosinhos Municipality
Hospital CUF Porto
Porto
Unidade Local de Saude da Arrabida E. P. E
Setúbal
Estonia2 sites
North Estonia Medical Centre Foundation
Tallinn
Tartu University Hospital
Tartu
Hungary2 sites
Orszagos Koranyi Pulmonologiai Intezet
Budapest
Bács-Kiskun County Hospital BKMK
Kecskemét
Puerto Rico2 sites
Pan American Oncology Trials, LLC
San Juan, 902
Auxilio Mutuo Cancer Center
San Juan, 917
About this study
Official title: A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)
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 locally advanced (unresectable stage IIIB/C) or 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 locally advanced (unresectable stage IIIB/C) or metastatic setting.
Read the detailed 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:
- non-small cell lung cancer that are locally advanced, unresectable stage IIIB/C or has metastasized (spread)
- tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)
- 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.
- Being tested
- Acasunlimab, Pembrolizumab, Docetaxel
- Keywords
- Lung Cancer, Solid Tumors, PD-L1, 4-1BB
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcasunlimabDrug
Also called GEN1046, DuoBody®-PD-L1×4-1BB
IV infusion
PembrolizumabDrug
IV infusion
DocetaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days). Receives: Drug: Acasunlimab; Drug: Pembrolizumab |
| Arm B | Active comparator | Docetaxel, 75 mg/m^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days). Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause.
Measured: Up to approximately 5 years
Secondary outcomes (9)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
Measured: Up to approximately 5 years
Confirmed Overall Response Rate (ORR)
Confirmed ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
Measured: Up to approximately 5 years
Duration of Response (DOR)
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator.
Measured: Up to approximately 5 years
Number of Participants With Adverse Events (AEs)
Measured: From first dose until the end of the study (approximately 5 years)
Time to Treatment Discontinuation Due to AE
Measured: From first dose until the end of the study (approximately 5 years)
Plasma Concentration of Acasunlimab
Measured: Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Acasunlimab
Serum samples will be analyzed using validated, specific, and sensitive immunoassay method. Samples will be screened for ADAs binding to acasunlimab and the titer of confirmed positive/negative samples will be reported.
Measured: Predose and postdose at multiple timepoints in Cycles 1-4 (Cycle length=42 days)
Change From Baseline in Functional Assessment of Cancer Therapy Item GP5 (FACIT-GP5; Version 4) Score
Participant's global assessment of treatment tolerability will be assessed by FACIT-GP5. FACIT-GP5 asks participants to rate their agreement with the following statement, "I am bothered by side effects of treatment" in the past 7 days. Responses will be captured on a 5-point Likert scale ranging from 0 to 4 indicating 0 as not at all to 4 as very much bothered by side effects.
Measured: Baseline up to approximately 2 years
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
The PRO-CTCAE allows participants to report on the frequency, severity, and interference of patient-reported symptoms. For each AE, there are between one and three items to assess the frequency, severity, and/or interference with activities related to that AE. All PRO-CTCAE responses will be scored from 0 to 4 for frequency indicating (0= never to 4= almost constantly), severity (0= none to 4= very severe) and interference with usual or daily activities (0= not at all to 4= very much).
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start25 Nov 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635824
- Sponsor's protocol ID
- GCT1046-06
- Other IDs
- 2024-512998-27-00, jRCT2051240178, 1010602, NL-OMON57246
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No