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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Budigalimab; Drug: Carboplatin; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Telisotuzumab Adizutecan; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Belgium
  • Liege
    • Liège, Liege, Belgium, 4000
      • Recruiting
      • Groupe Sante CHC - Clinique du MontLegia /ID# 271760
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Ziekenhuis - Campus Virga Jesse /ID# 268573
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Recruiting
      • AZ-Delta. /ID# 272433
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 269715
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Province Cancer Hospital /ID# 269150
  • Guangxi
    • Liuzhou, Guangxi, China, 545006
      • Recruiting
      • Liuzhou People's hospital /ID# 269667
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital - Tongji Medical College /ID# 272286
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Province Cancer Hospital /ID# 269679
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital /ID# 269762
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University /ID# 269190
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271904
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital /ID# 269155
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital /ID# 276397
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • First Affiliated Hospital of Shanxi Medical University /ID# 276482
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital /ID# 269712
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University /ID# 270244
  • Yunnan
    • Kunming, Yunnan, China, 650106
      • Recruiting
      • Yunnan Province Cancer Hospital /ID# 272331
• France
  • Loire-Atlantique
    • Saint-Herblain, Loire-Atlantique, France, 44800
      • Recruiting
      • CHU Nantes - Hopital Laennec /ID# 268475
  • Provence-Alpes-Côte d'Azur Region
    • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
      • Recruiting
      • Centre Antoine-Lacassagne /ID# 268486
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94805
      • Recruiting
      • Institut Gustave Roussy /ID# 258373
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75248
      • Recruiting
      • Institut Curie /ID# 271395
• Germany
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Recruiting
      • Universitaetsklinikum Freiburg /ID# 268473
    • Heilbronn, Baden-Wurttemberg, Germany, 74078
      • Recruiting
      • Slk-Kliniken Heilbronn /ID# 269621
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • Universitaetsklinikum Wuerzburg /ID# 275445
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Recruiting
      • Universitaetsklinikum Frankfurt /ID# 268721
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Recruiting
      • Universitaetsklinikum Koeln /ID# 268489
    • Hemer, North Rhine-Westphalia, Germany, 58675
      • Recruiting
      • Lungenklinik Hemer /ID# 269779
  • Schleswig-Holstein
    • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
      • Recruiting
      • ohO Research GmbH /ID# 273060
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Recruiting
      • Universitätsklinikum Jena /ID# 269700
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria delle Marche /ID# 268667
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 268675
  • Forlì-Cesena
    • Meldola, Forlì-Cesena, Italy, 47014
      • Recruiting
      • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
  • Milano
    • Milan, Milano, Italy, 20121
      • Recruiting
      • Istituto Europeo Di Oncologia /Id# 268670
  • Roma
    • Rome, Roma, Italy, 00144
      • Recruiting
      • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 268626
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Recruiting
      • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 268641
• Japan
  • Nagasaki, Japan, 852-8501
    • Recruiting
    • Nagasaki University Hospital /ID# 273310
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • Recruiting
      • NHO Nagoya Medical Center /ID# 272515
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center /ID# 271978
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Recruiting
      • Hirosaki University Hospital /ID# 274410
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 221-0855
      • Recruiting
      • Yokohama Municipal Citizen's Hospital /ID# 271979
  • Kyoto
    • Kyoto, Kyoto, Japan, 606-8507
      • Recruiting
      • Kyoto University Hospital /ID# 272312
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Recruiting
      • Niigata University Medical and Dental Hospital /ID# 274448
  • Osaka
    • Takatsuki, Osaka, Japan, 569-8686
      • Recruiting
      • Osaka Medical And Pharmaceutical University Hospital /ID# 273309
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital /ID# 273192
    • Koto-ku, Tokyo, Japan, 135-8550
      • Recruiting
      • The Cancer Institute Hospital Of JFCR /ID# 271989
• Poland
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-090
      • Recruiting
      • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie /ID# 273170
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Recruiting
      • Uniwersyteckie Centrum Kliniczne /ID# 272418
  • Świętokrzyskie Voivodeship
    • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
      • Recruiting
      • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 274549
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Recruiting
    • Pan American Center for Oncology Trials - Rio Piedras /ID# 268827
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario de Alicante Doctor Balmis /ID# 271316
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona /ID# 271452
  • Barcelona, Spain, 08003
    • Recruiting
    • Parc de Salut Mar - Hospital del Mar /ID# 271310
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital Santa Creu i Sant Pau /ID# 271311
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Virgen de la Victoria /ID# 271312
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Recruiting
      • Complejo Hospitalario Universitario A Coruña /ID# 271456
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla /ID# 271314
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Recruiting
      • Hospital Universitario Virgen Macarena /ID# 271447
• Taiwan
  • Changhua, Taiwan, 500
    • Recruiting
    • Changhua Christian Hospital /ID# 280139
  • Chiayi City, Taiwan, 62247
    • Recruiting
    • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 268139
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital /ID# 268138
  • Taipei, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital /ID# 269211
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center (Ntucc) /ID# 271586
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital /ID# 268787
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital /ID# 268137
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01140
    • Recruiting
    • Adana Medical Park Seyhan Hastanesi /ID# 272875
  • Ankara, Turkey (Türkiye), 06620
    • Recruiting
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 272873
  • Denizli, Turkey (Türkiye), 20070
    • Recruiting
    • Pamukkale Universitesi /ID# 272893
  • Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 272882
  • Samsun, Turkey (Türkiye), 55139
    • Recruiting
    • Ondokuz Mayis Universitesi /ID# 272899
  • Sakarya
    • Adapazarı, Sakarya, Turkey (Türkiye), 54290
      • Recruiting
      • Sakarya Egitim ve Arastirma Hastanesi /ID# 272878
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Velindre Cancer Centre /ID# 271840
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE1 5WW
      • Recruiting
      • Leicester Royal Infirmary /ID# 276035
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Active, not recruiting
      • Mayo Clinic Hospital - Phoenix /ID# 272971
  • California
    • Fullerton, California, United States, 92835
      • Recruiting
      • Providence - St. Jude Medical Center /ID# 271414
    • Oxnard, California, United States, 93030
      • Recruiting
      • FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
    • Santa Monica, California, United States, 90404
      • Recruiting
      • UCLA - Santa Monica /ID# 271690
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University Of Colorado - Anschutz Medical Campus /ID# 269069
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Hospital Jacksonville /ID# 275073
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Mid Florida Hematology And Oncology Center /ID# 273777
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Hope And Healing Cancer Services /ID# 276223
      • Contact: Site Coordinator; Phone Number: 6305600121
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Parkview Comprehensive Cancer Center /ID# 271879
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Community Health Network /ID# 273437
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Recruiting
      • Kansas City Cancer Center /ID# 273679
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute /ID# 278417
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Recruiting
      • St. Luke'S /ID# 273344
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic-Rochester /ID# 274512
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816-4096
      • Recruiting
      • Astera Cancer Care /ID# 271915
  • New York
    • Shirley, New York, United States, 11967
      • Recruiting
      • New York Cancer And Blood Specialists - Shirley /ID# 272547
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center /ID# 271726
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • The Mark H Zangmeister Center /ID# 272502
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
      • Recruiting
      • Spoknwrd Clinical Trials /ID# 273776
      • Contact: Site Coordinator; Phone Number: 610-813-2087
  • Texas
    • Houston, Texas, United States, 77090
      • Completed
      • Millennium Physicians /ID# 271717
    • Lubbock, Texas, United States, 79410-1121
      • Recruiting
      • Joe Arrington Cancer Research /ID# 272776
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute /ID# 271686
  • Virginia
    • Leesburg, Virginia, United States, 20176
      • Recruiting
      • Virgnia Cancer Specialists /ID# 269633
  • Washington
    • Olympia, Washington, United States, 98506
      • Recruiting
      • Vista Oncology - East Olympia /ID# 275438
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties Tacoma /ID# 270469

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Telisotuzumab Adizutecan + Budigalimab; Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.	Drug: Budigalimab; IV Infusion; Other Names: ABBV-181; Drug: Telisotuzumab Adizutecan; Intravenous (IV) Infusion; Other Names: ABBV-400
Experimental: Part 2: Standard of Care; 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.	Drug: Carboplatin; IV Infusion; Drug: Pembrolizumab; IV Infusion; Drug: Cisplatin; IV Infusion; Drug: Pemetrexed; IV Infusion; Drug: Pembrolizumab; IV Injection
Experimental: Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab; Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration.	Drug: Pembrolizumab; IV Infusion; Drug: Telisotuzumab Adizutecan; Intravenous (IV) Infusion; Other Names: ABBV-400; Drug: Pembrolizumab; IV Injection
Experimental: Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab; Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration.	Drug: Pembrolizumab; IV Infusion; Drug: Telisotuzumab Adizutecan; Intravenous (IV) Infusion; Other Names: ABBV-400; Drug: Pembrolizumab; IV Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to Approximately 33 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to Approximately 33 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cisplatin; Pembrolizumab; Carboplatin; Pemetrexed; ABBV-181; Budigalimab; ABBV-400; Non Small Cell Lung Carcinoma; Telisotuzumab Adizutecan; AndroMETa-Lung-536
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab; budigalimab
• Other Study ID Numbers: M24-536; 2024-514465-18 (Other Identifier: EU CT); 2024-514465-18-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes