A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (NCT06568939) — Singapore Trial Details

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Telisotuzumab Vedotin: Intravenous (IV) Infusion

Study summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.

Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory * Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic. * Must have a known epidermal growth factor receptor (EGFR) activating mutation status. * Actionable alterations in genes other than EGFR are permitted. * Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol. * Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol. Exclusion Criteria: * Adenosquamous or neuroendocrine histology, or sarcomatoid features. * EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations). * Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E. * Received prior docetaxel therapy. * Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol. * History of other malignancies except those stated in the protocol. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol. * Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study. * Major surgery within 21 days prior to randomization. * Clinically significant condition(s) including but not limited to those listed in the protocol. * Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. * Grade \>= 2 edema or lymphedema. * Grade \>= 2 ascites or pleural effusion. * Grade \>= 2 neuropathy. * Active uncontrolled bacterial or viral infection. * Active corneal disorder.

Primary outcome measure(s)

Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2) — Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD) — Up to Approximately 3 Years
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy — Up to Approximately 3 Years
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders — Up to Approximately 3 Years
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation — Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Percentage of Participants with Grade 5 Treatment-Emergent AEs — Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Objective Response (OR) by Blinded Independent Central Review (BICR) — Up to Approximately 3 Years
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.

Trial sites (82)

Facility	City	Region	Status
Ironwood Cancer and Research Center /ID# 276370	Chandler	Arizona	Recruiting
University of Arkansas for Medical Sciences /ID# 272923	Little Rock	Arkansas	Recruiting
Start Los Angeles /ID# 284999	Los Angeles	California	Recruiting
Valkyrie Clinical Trials /ID# 271322	Los Angeles	California	Recruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816	Oxnard	California	Recruiting
Yale New Haven Hospital /ID# 271584	New Haven	Connecticut	Recruiting
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899	Jacksonville	Florida	Recruiting
Ocala Oncology Center /ID# 273697	Ocala	Florida	Recruiting
Memorial Hospital West /ID# 270313	Pembroke Pines	Florida	Recruiting
Comprehensive Hematology Oncology /ID# 270422	St. Petersburg	Florida	Recruiting
Florida Cancer Specialists - North /ID# 271995	St. Petersburg	Florida	Recruiting
Florida Cancer Specialists - East /ID# 271993	West Palm Beach	Florida	Recruiting
University Cancer & Blood Center /ID# 270969	Athens	Georgia	Recruiting
Northwest Georgia Oncology Centers /ID# 275374	Marietta	Georgia	Recruiting
Memorial University Medical Center /ID# 272467	Savannah	Georgia	Completed
Kaiser Permanente Moanalua Medical Center /ID# 272916	Honolulu	Hawaii	Recruiting
University of Illinois Hospital and Health Sciences System /ID# 275345	Chicago	Illinois	Recruiting
Illinois Cancer Specialists /ID# 274678	Niles	Illinois	Recruiting
Springfield Clinic - First /ID# 272576	Springfield	Illinois	Recruiting
Nebraska Hematology-Oncology /ID# 272970	Lincoln	Nebraska	Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527	Omaha	Nebraska	Recruiting
Renown Regional Medical Center /ID# 273535	Reno	Nevada	Recruiting
Astera Cancer Care /ID# 272359	East Brunswick	New Jersey	Recruiting
Regional Cancer Care Associates /ID# 270783	Teaneck	New Jersey	Recruiting
Montefiore Medical Center - Einstein Campus /ID# 277169	The Bronx	New York	Recruiting
Clinical Research Alliance - Westbury /ID# 270455	Westbury	New York	Recruiting
FirstHealth of the Carolinas- Speciality Center /ID# 272924	Pinehurst	North Carolina	Recruiting
Mercy Health - Perrysburg Cancer Center /ID# 270536	Perrysburg	Ohio	Recruiting
Genesis Healthcare System /ID# 273361	Zanesville	Ohio	Recruiting
Guthrie Robert Packer Hospital /ID# 270316	Sayre	Pennsylvania	Recruiting
Cancer Care Associates Of York /ID# 270971	York	Pennsylvania	Recruiting
Medical University of South Carolina /ID# 273272	Charleston	South Carolina	Recruiting
Saint Francis Cancer Center - Greenville /ID# 276368	Greenville	South Carolina	Recruiting
SCRI Oncology Partners /ID# 270162	Nashville	Tennessee	Recruiting
Texas Oncology - Dallas - Worth Street /ID# 278947	Dallas	Texas	Recruiting
Texas Oncology - Northeast Texas /ID# 272000	Tyler	Texas	Recruiting
Community Cancer Trials Of Utah /ID# 276598	Ogden	Utah	Recruiting
Virginia Cancer Specialists - Fairfax /ID# 272004	Fairfax	Virginia	Recruiting
Medical Oncology Associates - Spokane /ID# 277172	Spokane	Washington	Recruiting
Northwest Medical Specialties Tacoma /ID# 270534	Tacoma	Washington	Recruiting

+ 42 more sites — see the full list on the official registry below.

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