問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberM22-137
NCT Number(ClinicalTrials.gov Identfier)NCT05513703
Active

2022-12-01 - 2024-10-28

Phase II

Recruiting4

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張晃智 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non Small Cell Lung Cancer

Objectives

The main purpose is to confirm: - Overall response rate (ORR) with telisotuzumab vedotin in previously untreated subjects with non-squamous NSCLC and MET gene amplification. The secondary purpose is to confirm: - Duration of response (DoR); - Disease control rate (DCR); - Progression-free survival (PFS); - Overall survival (OS); - "Time to worsening of cough, pain or dyspnea" as measured by the cough or pain and dyspnea items of the European Organization for Research and Treatment of Cancer Lung Cancer Quality of Life Questionnaire Module 13 (EORTC QLQ-LC13); - "Time to deterioration of physiological function" according to the physiological function domain assessment of EORTC-QLQ-Core 30 (EORTC QLQ-C30); - "Changes in quality of life compared to the base period" based on the overall health status/quality of life domain assessment of EORTC QLQ-C30; - Safety and tolerability.

Test Drug

Telisotuzumab vedotin (ABBV-399)

Active Ingredient

Telisotuzumab vedotin (ABBV-399)

Dosage Form

Powder for Solution for Infusion

Dosage

100 mg

Endpoints

Overall response rate (ORR) as assessed by an independent central review panel (ICR). ORR was defined as the proportion of subjects with a complete response (CR) or partial response (PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Inclution 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

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.

The Estimated Number of Participants

  • Taiwan

    4 participants

  • Global

    70 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB