Clinical trial NCT06568939: 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)
Official title: A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
NSCLC
Telisotuzumab Vedotin
ABBV-399
TeliMET NSCLC-04
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 70 to 80 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 criteria: Inclusion Criteria:

* Projected life expectancy of at least 12 weeks.
* Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie 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.
* Actionable EGFR activating 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 outcomes:
measure: Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
timeFrame: Up to Approximately 3 Years
measure: Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)
timeFrame: Up to Approximately 3 Years
measure: Percentage of Participants with Treatment-Emergent Peripheral Neuropathy
timeFrame: Up to Approximately 3 Years
measure: Percentage of Participants with Treatment-Emergent Ocular Surface Disorders
timeFrame: Up to Approximately 3 Years
measure: Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation
timeFrame: Up to Approximately 3 Years
measure: Percentage of Participants with Grade 5 Treatment-Emergent AEs
timeFrame: Up to Approximately 3 Years
measure: Objective Response (OR) by Blinded Independent Central Review (BICR)
timeFrame: Up to Approximately 3 Years
Secondary outcomes:
measure: Concentrations of Telisotuzumab Vedotin Conjugate in Serum
timeFrame: Up to 26 Weeks
measure: Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma
timeFrame: Up to 26 Weeks
measure: Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin
timeFrame: Up to 26 Weeks
measure: Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin
timeFrame: Up to 26 Weeks
measure: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
measure: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
measure: Duration of Response (DoR) by BICR
timeFrame: Up to Approximately 3 Years
measure: Progression-Free Survival (PFS) by BICR
timeFrame: Up to Approximately 3 Years
measure: Overall Survival (OS)
timeFrame: Up to Approximately 3 Years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital /ID# 271584
state: Connecticut
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center /ID# 273697
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology /ID# 270422
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - North /ID# 271995
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists - East /ID# 271993
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center /ID# 270969
state: Georgia
city: Springfield
country: United States
facility: Springfield Clinic /ID# 272576
state: Illinois
city: Lincoln
country: United States
facility: NHO - Nebraska Hematology-Oncology /ID# 272970
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
state: Nebraska
city: East Brunswick
country: United States
facility: Astera Cancer Care /ID# 272359
state: New Jersey
city: Westbury
country: United States
facility: Clinical Research Alliance - Westbury /ID# 270455
state: New York
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas- Speciality Center /ID# 272924
state: North Carolina
city: Perrysburg
country: United States
facility: Mercy Health - Perrysburg Cancer Center /ID# 270536
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System /ID# 273361
state: Ohio
city: Sayre
country: United States
facility: Guthrie Robert Packer Hospital /ID# 270316
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates Of York /ID# 270971
state: Pennsylvania
city: Nashville
country: United States
facility: SCRI Oncology Partners /ID# 270162
state: Tennessee
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 272000
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 272004
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties Tacoma /ID# 270534
state: Washington
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University /ID# 271935
state: Beijing
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital - Tongji Medical College /ID# 271668
state: Hubei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 271666
state: Jiangxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
state: Shaanxi
city: Linyi
country: China
facility: Linyi Cancer Hospital /ID# 272068
state: Shandong
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 270078
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 270071
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 270095
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 270087
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore /ID# 271499
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital /ID# 271700
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: