Non Small Cell Lung CarcinomaPhase 1/2NCT06772623
Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
A Phase 1/2 study testing Telisotuzumab Adizutecan, Budigalimab and Pembrolizumab in people with Non Small Cell Lung Carcinoma and c-MET, run by AbbVie at 126 sites in 16 countries.
Trial summary
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma, c-MET
- What is being tested?
- Telisotuzumab Adizutecan, Budigalimab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 126 sitesin 16 countries
- Study dates
- 6 Mar 2025to Nov 2027
- Phase
- Phase 1/2
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
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
- Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
- For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
- For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
- Must have documented programmed death ligand 1 (PD-L1) status.
- For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.
- Must have adequate organ function.
Who cannot join
- Known uncontrolled metastases to the central nervous system.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Trial locations and contacts
126 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
126 sites in 16 countries
United States27 sites, 23 recruiting
- Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, Colorado, 80045
- Recruiting
Dana-Farber Cancer Institute /ID# 278417
Boston, Massachusetts, 02215
- Completed
University Hospitals Cleveland Medical Center /ID# 271726
Cleveland, Ohio, 44106
- Recruiting
The Mark H Zangmeister Center /ID# 272502
Columbus, Ohio, 43219
- Recruiting
Henry Ford Hospital - Detroit /ID# 271642
Detroit, Michigan, 48202
- Recruiting
St. Luke'S /ID# 273344
Duluth, Minnesota, 55805
- Recruiting
Astera Cancer Care /ID# 271915
East Brunswick, New Jersey, 08816-4096
- Recruiting
Spoknwrd Clinical Trials /ID# 273776
Easton, Pennsylvania, 18045
Site Coordinator, 610-813-2087
- Recruiting
Parkview Comprehensive Cancer Center /ID# 271879
Fort Wayne, Indiana, 46845
- Recruiting
Providence - St. Jude Medical Center /ID# 271414
Fullerton, California, 92835
- Recruiting
Hope And Healing Cancer Services /ID# 276223
Hinsdale, Illinois, 60521
Site Coordinator, 6305600121
- Completed
Millennium Physicians /ID# 271717
Houston, Texas, 77090
- Completed
Community Health Network /ID# 273437
Indianapolis, Indiana, 46202
- Recruiting
Mayo Clinic Hospital Jacksonville /ID# 275073
Jacksonville, Florida, 32224
- Recruiting
Virgnia Cancer Specialists /ID# 269633
Leesburg, Virginia, 20176
- Recruiting
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, Colorado, 80124
- Recruiting
Joe Arrington Cancer Research /ID# 272776
Lubbock, Texas, 79410-1121
- Recruiting
Vista Oncology - East Olympia /ID# 275438
Olympia, Washington, 98506
- Recruiting
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, Florida, 32763
- Recruiting
Kansas City Cancer Center /ID# 273679
Overland Park, Kansas, 66210
- Recruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, California, 93030
- Active, not recruiting
Mayo Clinic Hospital - Phoenix /ID# 272971
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic-Rochester /ID# 274512
Rochester, Minnesota, 55905
- Recruiting
Huntsman Cancer Institute /ID# 271686
Salt Lake City, Utah, 84112
- Recruiting
UCLA - Santa Monica /ID# 271690
Santa Monica, California, 90404
- Recruiting
New York Cancer And Blood Specialists - Shirley /ID# 272547
Shirley, New York, 11967
- Recruiting
Northwest Medical Specialties Tacoma /ID# 270469
Tacoma, Washington, 98405
China15 sites, 15 recruiting
- Recruiting
Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715
Beijing, Beijing Municipality, 100021
- Recruiting
Hunan Province Cancer Hospital /ID# 269679
Changsha, Hunan, 410013
- Recruiting
Sichuan Cancer Hospital /ID# 269712
Chengdu, Sichuan, 610041
- Recruiting
West China Hospital of Sichuan University /ID# 270244
Chengdu, Sichuan, 610041
- Recruiting
Fujian Province Cancer Hospital /ID# 269150
Fuzhou, Fujian, 350014
- Recruiting
Yunnan Province Cancer Hospital /ID# 272331
Kunming, Yunnan, 650106
- Recruiting
Liuzhou People's hospital /ID# 269667
Liuzhou, Guangxi, 545006
- Recruiting
The First Affiliated Hospital of Nanchang University /ID# 269190
Nanchang, Jiangxi, 330006
- Recruiting
Nanjing Drum Tower Hospital /ID# 269762
Nanjing, Jiangsu, 210008
- Recruiting
Shanghai Chest Hospital /ID# 269155
Shanghai, Shanghai Municipality, 200030
- Recruiting
Shanghai Pulmonary Hospital /ID# 276397
Shanghai, Shanghai Municipality, 200433
- Recruiting
First Affiliated Hospital of Shanxi Medical University /ID# 276482
Taiyuan, Shanxi, 030001
- Recruiting
Union Hospital - Tongji Medical College /ID# 272286
Wuhan, Hubei, 430022
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904
Xi'an, Shaanxi, 710061
- Recruiting
Henan Cancer Hospital /ID# 269668
Zhengzhou, Henan, 450008
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi /ID# 272875
Adana, 01140
- Recruiting
Sakarya Egitim ve Arastirma Hastanesi /ID# 272878
Adapazarı, Sakarya, 54290
- Recruiting
Gulhane Egitim ve Arastirma Hastanesi /ID# 280715
Ankara, Antalya, 06010
- Recruiting
Hacettepe Universitesi Tip Fakultesi /ID# 280631
Ankara, 06230
- Recruiting
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873
Ankara, 06620
- Recruiting
Liv Hospital Ankara /ID# 272876
Ankara, 06680
- Recruiting
Pamukkale Universitesi /ID# 272893
Denizli, 20070
- Recruiting
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 280635
Istanbul, 34722
- Recruiting
Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 272882
Konya, 42080
- Recruiting
Ondokuz Mayis Universitesi /ID# 272899
Samsun, 55139
- Recruiting
Samsun Medical Park Hastanesi /ID# 272880
Samsun, 55200
Japan10 sites, 10 recruiting
- Recruiting
National Cancer Center Hospital /ID# 273192
Chuo-Ku, Tokyo, 104-0045
- Recruiting
Hirosaki University Hospital /ID# 274410
Hirosaki, Aomori, 036-8563
- Recruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 271989
Koto-ku, Tokyo, 135-8550
- Recruiting
Kyoto University Hospital /ID# 272312
Kyoto, Kyoto, 606-8507
- Recruiting
Nagasaki University Hospital /ID# 273310
Nagasaki, 852-8501
- Recruiting
NHO Nagoya Medical Center /ID# 272515
Nagoya, Aichi-ken, 460-0001
- Recruiting
Aichi Cancer Center /ID# 271978
Nagoya, Aichi-ken, 464-8681
- Recruiting
Niigata University Medical and Dental Hospital /ID# 274448
Niigata, Niigata, 951-8520
- Recruiting
Osaka Medical And Pharmaceutical University Hospital /ID# 273309
Takatsuki, Osaka, 569-8686
- Recruiting
Yokohama Municipal Citizen's Hospital /ID# 271979
Yokohama, Kanagawa, 221-0855
Germany9 sites, 9 recruiting
- Recruiting
Hamatologie-Onkologie im Zentrum MVZ GmbH /ID# 273043
Augsburg, Bavaria, 86150
- Recruiting
Universitaetsklinikum Koeln /ID# 268489
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Universitaetsklinikum Frankfurt /ID# 268721
Frankfurt am Main, Hesse, 60590
- Recruiting
Universitaetsklinikum Freiburg /ID# 268473
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Slk-Kliniken Heilbronn /ID# 269621
Heilbronn, Baden-Wurttemberg, 74078
- Recruiting
Lungenklinik Hemer /ID# 269779
Hemer, North Rhine-Westphalia, 58675
- Recruiting
Universitatsklinikum Jena /ID# 269700
Jena, Thuringia, 07747
- Recruiting
ohO Research GmbH /ID# 273060
Oldenburg in Holstein, Schleswig-Holstein, 23758
- Recruiting
Universitaetsklinikum Wuerzburg /ID# 275445
Würzburg, Bavaria, 97080
Spain8 sites, 8 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna /ID# 271456
A Coruña, 15006
- Recruiting
Hospital General Universitario de Alicante /ID# 271316
Alicante, 03010
- Recruiting
Parc de Salut Mar - Hospital del Mar /ID# 271310
Barcelona, 08003
- Recruiting
Hospital Clinic de Barcelona /ID# 271452
Barcelona, 08036
- Recruiting
Hospital Santa Creu i Sant Pau /ID# 271311
Barcelona, 08041
- Recruiting
Hospital Universitario Virgen de la Victoria /ID# 271312
Málaga, 29010
- Recruiting
Hospital Universitario Marques de Valdecilla /ID# 271314
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen Macarena /ID# 271447
Seville, Sevilla, 41009
Taiwan8 sites, 8 recruiting
- Recruiting
Changhua Christian Hospital /ID# 280139
Changhua, 500
- Recruiting
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
Chiayi City, 62247
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139
Kaohsiung City, 807
- Recruiting
Kaohsiung Chang Gung Memorial Hospital /ID# 268138
Kaohsiung City, 833
- Recruiting
National Taiwan University Cancer Center (Ntucc) /ID# 271586
Taipei, 106
- Recruiting
Taipei Veterans General Hospital /ID# 268787
Taipei, 112
- Recruiting
Tri-Service General Hospital /ID# 269211
Taipei, 114
- Recruiting
Linkou Chang Gung Memorial Hospital /ID# 268137
Taoyuan City, 333
France7 sites, 7 recruiting
- Recruiting
Institut Bergonie /ID# 258377
Bordeaux, Gironde, 33000
- Recruiting
Centre De Cancerologie Du Grand Montpellier /ID# 273724
Montpellier, Occitanie, 34070
- Recruiting
Centre Antoine-Lacassagne /ID# 268486
Nice, Provence-Alpes-Côte d'Azur Region, 06189
- Recruiting
Institut Curie /ID# 271395
Paris, Île-de-France Region, 75248
- Recruiting
CHU Nantes - Hopital Laennec /ID# 268475
Saint-Herblain, Loire-Atlantique, 44800
- Recruiting
Institut de Cancerologie de l'Ouest Rene Gauducheau /ID# 268484
Saint-Herblain, Loire-Atlantique, 44805
- Recruiting
Institut Gustave Roussy /ID# 258373
Villejuif, Val-de-Marne, 94805
Italy7 sites, 7 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche /ID# 268667
Ancona, The Marches, 60126
- Recruiting
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675
Bologna, 40138
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
Meldola, Forlì-Cesena, 47014
- Recruiting
Istituto Europeo Di Oncologia /Id# 268670
Milan, Milano, 20121
- Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 268641
Orbassano, Torino, 10043
- Recruiting
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626
Rome, Roma, 00144
- Recruiting
Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 273438
Rome, Roma, 00184
Romania6 sites, 6 recruiting
- Recruiting
MNT Healthcare Europe SRL /ID# 269075
Bucharest, 013975
- Recruiting
Spitalul Clinic Coltea /ID# 268726
Bucharest, 030171
- Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 268725
Cluj-Napoca, Cluj, 400015
- Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca /ID# 273125
Cluj-Napoca, Cluj, 400015
- Recruiting
S.C. Radiotherapy Center Cluj SRL /ID# 268729
Cluj-Napoca, Cluj, 400080
- Recruiting
Clinica MedLife Polisano Sibiu /ID# 269078
Sibiu, 550253
Australia4 sites, 4 recruiting
- Recruiting
Blacktown Hospital /ID# 281588
Blacktown, New South Wales, 2148
- Recruiting
Lyell Mcewin Hospital /ID# 281860
Elizabeth Vale, South Australia, 5112
- Recruiting
Peninsula University Hospital /ID# 281824
Frankston, Victoria, 3199
- Recruiting
Townsville University Hospital /ID# 281498
Townsville, Queensland, 4814
Belgium4 sites, 4 recruiting
- Recruiting
Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573
Hasselt, Limburg, 3500
- Recruiting
Groupe Sante CHC - Clinique du MontLegia /ID# 271760
Liège, 4000
- Recruiting
AZ-Delta. /ID# 272433
Roeselare, West-Vlaanderen, 8800
- Recruiting
Vitaz /Id# 280187
Sint-Niklaas, Oost-Vlaanderen, 9100
Poland4 sites, 4 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 276848
Bialystok, Podlaskie Voivodeship, 15-540
- Recruiting
Uniwersyteckie Centrum Kliniczne /ID# 272418
Gdansk, Pomeranian Voivodeship, 80-214
- Recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 274549
Kielce, Świętokrzyskie Voivodeship, 25-734
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 273170
Lublin, Lublin Voivodeship, 20-090
Argentina3 sites, 3 recruiting
- Recruiting
Centro Oncologico Korben /ID# 281460
Buenos Aires, 1426
- Recruiting
Fundacion Respirar /ID# 281039
Buenos Aires, 1426
- Recruiting
Instituto Alexander Fleming /ID# 282704
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1426
United Kingdom2 sites, 2 recruiting
- Recruiting
Velindre Cancer Centre /ID# 271840
Cardiff, CF14 2TL
- Recruiting
University Hospitals of Leicester NHS Trust /ID# 276035
Leicester, Leicestershire, LE1 5WW
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 268827
Rio Piedras, 00935
About this study
Official title: An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
Read more
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
- Conditions
- Non Small Cell Lung Carcinoma, c-MET
- Being tested
- Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab, Carboplatin, Pemetrexed
- Keywords
- Non Small Cell Lung Carcinoma, Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, Telisotuzumab Adizutecan, ABBV-400, ABBV-181, Budigalimab, AndroMETa-Lung-536
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Also called ABBV-400
Intravenous (IV) Infusion
BudigalimabDrug
Also called ABBV-181
IV Infusion
PembrolizumabDrug
IV Injection
PembrolizumabDrug
IV Infusion
CarboplatinDrug
IV Infusion
PemetrexedDrug
IV Infusion
CisplatinDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Telisotuzumab Adizutecan + Budigalimab | Experimental | Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration. Receives: Drug: Telisotuzumab Adizutecan; Drug: Budigalimab |
| Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab | Experimental | Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration. Receives: Drug: Telisotuzumab Adizutecan; Drug: Pembrolizumab |
| Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab | Experimental | Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration. Receives: Drug: Telisotuzumab Adizutecan; Drug: Pembrolizumab |
| Part 2: Standard of Care | Experimental | Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Measured: Up to Approximately 84 Days
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to Approximately 33 Months
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 33 Months
Secondary outcomes (9)
Part 1 and Part 2: PFS as Assessed by Investigator
PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per Investigator based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Measured: Up to Approximately 33 Months
Part 1 and Part 2: DOR as Assessed by Investigator
DOR is defined as the time from the first documented CR or PR per investigator to the first occurrence of radiographic progression per the investigator on RECIST v1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Measured: Up to Approximately 33 Months
Part 1 and Part 2: DC as Assessed by Investigator
DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 11 weeks following randomization date based on RECIST v1.1, as determined by the Investigator.
Measured: Up to Approximately 33 Months
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from participant's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause.
Measured: Up to Approximately 33 Months
Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR
OR is defined as confirmed CR or confirmed PR based on RECIST v1.1.
Measured: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: PFS
PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Measured: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: OS
OS is defined as the time from participant's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause.
Measured: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: DOR
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Measured: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: DC
DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1.
Measured: Up to Approximately 33 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start6 Mar 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772623
- Sponsor's protocol ID
- M24-536
- Other IDs
- 2024-514465-18, 2024-514465-18-00
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.