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)

Non Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05513703
• Other study ID #: M22-137
• Secondary ID: 2022-500608-23-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 21, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: March 31, 2026
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Biological:
• Telisotuzumab Vedotin
Intravenous (IV) Infusion

Locations

Country	Name	City	State
Australia	Monash Medical Centre /ID# 247679	Clayton	Victoria
France	HCL - Hopital Louis Pradel /ID# 246267	Bron	Rhone
France	Centre Jean Perrin /ID# 246268	Clermont Ferrand
France	CHU Lille - Hôpital Albert Calmette /ID# 246263	Lille	Hauts-de-France
Germany	Asklepios Fachkliniken Muenchen-Gauting /ID# 248082	Gauting
Israel	Rabin Medical Center /ID# 248631	Haifa	H_efa
Israel	Rambam Health Care Campus /ID# 246781	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 243298	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 243208	Kfar Saba	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 243207	Ramat Gan	Tel-Aviv
Italy	Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329	Candiolo	Torino
Italy	Fondazione IRCCS San Gerardo dei Tintori /ID# 247584	Monza	Monza E Brianza
Italy	IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585	Rome
Japan	National Cancer Center Hospital /ID# 250319	Chuo-ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center /ID# 250714	Fukuoka-shi	Fukuoka
Japan	National Cancer Center Hospital East /ID# 250317	Kashiwa-shi	Chiba
Japan	Osaka International Cancer Institute /ID# 251507	Osaka-shi	Osaka
Japan	Hokkaido University Hospital /ID# 250316	Sapporo-shi	Hokkaido
Japan	Shizuoka Cancer Center /ID# 251752	Sunto-gun	Shizuoka
Korea, Republic of	Chungbuk National Univ Hosp /ID# 248405	Cheongju
Korea, Republic of	Keimyung University Dongsan Medical Center /ID# 247371	Daegu
Korea, Republic of	Samsung Medical Center /ID# 248407	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital /ID# 248489	Yangsan-si	Gyeongsangnamdo
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 248144	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 248143	Kaohsiung City	Kaohsiung
Taiwan	National Cheng Kung University Hospital /ID# 248142	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 248145	Taoyuan City
United States	Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671	Los Alamitos	California
United States	Valley Medical Center /ID# 251880	Renton	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) as Assessed by an Independent Central Review (ICR)	ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.	Up to 1 Year
Secondary	Duration of Response (DoR)	DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.	Up to 1 Year
Secondary	Disease Control Rate (DCR)	DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.	Up to 1 Year
Secondary	Progression Free Survival (PFS) per ICR	PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.	Up to 1 Year
Secondary	Overall Survival (OS)	OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.	Up to 2 Years
Secondary	Time to Deterioration in Cough	Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).	Up to 1 Year
Secondary	Time to Deterioration in Pain	Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.	Up to 1 Year
Secondary	Time to Deterioration in Dyspnea	Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.	Up to 1 Year
Secondary	Time to Deterioration of Physical Functioning	Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).	Up to 1 Year
Secondary	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).	The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.	Up to 1 Year

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