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Clinical Trials List

Protocol NumberM14-239
NCT Number(ClinicalTrials.gov Identfier)NCT03539536
Active

2019-03-06 - 2022-02-28

Phase II

Recruiting11

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.0

Malignant neoplasm of trachea

Phase 2 open trial to evaluate the safety and efficacy of Telisotuzumab Vedotin (ABBV-399) in subjects with previously treated c-Met+ non-small cell lung cancer

  • Trial Applicant

    AbbVie

  • Sponsor

    abbive

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Shang-Yin Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsi Kuo Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Hematology & Oncology
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

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 Chia-Chi Lin 無
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yin Wu 無
National Cheng Kung University Hospital Dou-Liou Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱倫瑋 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

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

Condition/Disease

NSCLC

Objectives

The main purpose is to understand the overall response rate (ORR) of telisotuzumab vedotin in c-Met+ NSCLC subjects.

Test Drug

Telisotuzumab Vedotin (ABBV-399)

Active Ingredient

ABBV-399

Dosage Form

powder

Dosage

100mg

Endpoints

ORR is defined as confirming a complete response (CR) or confirming a partial response (PR)
The proportion of subjects was evaluated based on RECIST Version 1.1.

Inclution Criteria

Inclusion conditions
It is confirmed by histology to be non-squamous cell NSCLC and its EGFR status is known (wild type or mutation; and the test unit has recorded its status), or confirmed by histology to be squamous cell NSCLC. Please note that as long as the EGFR status is known and any other eligibility criteria are met, subjects with other actionable mutations are still eligible.
The subject must have locally worsening or metastatic NSCLC.
The subject must have NSCLC evaluated as c-Met+ by the IHC laboratory designated by AbbVie or a known and documented MET gene increase.
If the remaining tissue samples confirm that the subject meets the eligibility criteria for c-Met protein expression, or the MET amplification status, the subject must agree to provide fresh tumor tissue to assess c-Met protein expression before inclusion.
Subjects using systemic cytotoxic therapy (or not applicable) and immune checkpoint inhibitors (used alone or in combination with systemic cytotoxic chemotherapy or not applicable), and after changing carcinogenic driver gene anti-cancer therapy (if applicable) The disease worsened.
Subjects received no more than 2 lines of systemic therapy in the metastatic state (including previous systemic cytotoxic chemotherapy with no more than 1 line).
->For this eligibility criterion, a multi-line TKI for the same TK is deemed to receive first-line treatment.
The subjects had a physical status score of 0 to 1 in the East Coast Cancer Clinical Research Cooperation Organization (ECOG).

Exclusion Criteria

Exclude conditions
The subject was in the state of adenosquamous tissue.
Subjects with central nervous system (CNS) metastases are only eligible after receiving definitive treatment (such as surgery or radiotherapy).
The subject has a clinically significant condition described in the plan.
The subject has a clinically significant adverse reaction of grade 2 or above that has not recovered due to the anti-cancer treatment previously received, except for alopecia or anemia.
The subject had undergone major surgery within 21 days before receiving the first dose of telisotuzumab vedotin.
The subjects received the live vaccine within 30 days of receiving the first dose of telisotuzumab vedotin.
The subject has a history of interstitial lung disease or pneumonitis that requires systemic steroid therapy, or any evidence of active interstitial lung disease or lung inflammation (pneumonitis).

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    310 participants

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