Clinical trial NCT05513703: A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: c-Met NSCLC
Telisotuzumab Vedotin
ABBV-399
Cancer
Non Small Cell Lung Cancer
NSCLC
MET Amplified NSCLC
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-08-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

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:

* Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay.
* Must have histologically documented non-squamous adenocarcinoma non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
* 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 or 1.
* Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed \>= 6 months before subject's first dose of study drug.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Exclusion Criteria:

* Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
* Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression.
* Have a history of other malignancies except those noted in the protocol.
* Have a 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.
* Received prior c-Met-targeted antibodies.
* Have NSCLC that is eligible for treatment with curative intent.
* Have unresolved adverse events (AEs) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
* Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
* Have clinically significant condition(s) as noted in the protocol.

Primary outcomes:
measure: Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)
timeFrame: Up to 1 Year
Secondary outcomes:
measure: Duration of Response (DoR)
timeFrame: Up to 1 Year
measure: Disease Control Rate (DCR)
timeFrame: Up to 1 Year
measure: Progression Free Survival (PFS) per ICR
timeFrame: Up to 1 Year
measure: Overall Survival (OS)
timeFrame: Up to 2 Years
measure: Time to Deterioration in Cough
timeFrame: Up to 1 Year
measure: Time to Deterioration in Pain
timeFrame: Up to 1 Year
measure: Time to Deterioration in Dyspnea
timeFrame: Up to 1 Year
measure: Time to Deterioration of Physical Functioning
timeFrame: Up to 1 Year
measure: Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671
state: California
city: Renton
country: United States
facility: Valley Medical Center /ID# 251880
state: Washington
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 247679
state: Victoria
city: Lille
country: France
facility: CHU Lille - Hôpital Albert Calmette /ID# 246263
state: Hauts-de-France
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 246267
state: Rhone
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin /ID# 246268
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 248082
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 246781
state: H_efa
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 243208
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 243207
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 243298
state: Yerushalayim
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 248631
city: Monza
country: Italy
facility: Duplicate_Fondazione IRCCS San Gerardo dei Tintori /ID# 247584
state: Monza E Brianza
city: Candiolo
country: Italy
facility: Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329
state: Torino
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 250317
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 250714
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 250316
state: Hokkaido
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute /ID# 251507
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 251752
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 250319
state: Tokyo
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 248405
state: Chungcheongbugdo
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 247371
state: Gyeongsangbugdo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 248489
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 248407
state: Seoul Teugbyeolsi
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 248143
state: Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 248142
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 248145
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: