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

Clinical Trials List

Protocol NumberM16-298
NCT Number(ClinicalTrials.gov Identfier)NCT03033511

2017-05-15 - 2020-04-09

Phase III

Terminated8

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 何景良 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hua Chiu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Terminated

Audit

None

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jen-Yu Hung 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

CRO

Principal Investigator Chong-Jen Yu Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

Condition/Disease

Extensive Stage Small Cell Lung Cancer

Objectives

Objectives: Primary  To evaluate if rovalpituzumab tesirine improves progression-free and overall survival in subjects with extensive-stage small cell lung cancer (ED SCLC) who have ongoing clinical benefit (SD, PR, or CR) following first-line platinum-based chemotherapy (cisplatin or carboplatin plus irinotecan or etoposide) compared to placebo. Secondary  To evaluate rovalpituzumab tesirine anti-tumor activity by determining objective response rate (ORR), clinical benefit rate (CBR), and duration of responses (DOR)  To assess change in patient reported outcomes (PRO) with EORTC QLQ-C30/LC13 questionnaires. Exploratory  To characterize the pharmacokinetics and incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine  To evaluate pharmacodynamic and predictive biomarkers in blood and tumor for association with sensitivity, efficacy and safety  To explore DLL3 expression in circulating tumor cells (CTCs) for association with efficacy  To assess EQ-5D-5L during treatment with rovalpituzumab tesirine.

Test Drug

Rovalpituzumab Tesirine(Rova-T)

Active Ingredient

Rovalpituzumab Tesirine(Rova-T)

Dosage Form

injection

Dosage

30mg/10ml

Endpoints

Efficacy: Efficacy assessments will consist of evaluations for tumor progression using Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1 and will be based on a Central Radiographic
Assessment Committee (CRAC) review of medical images, as outlined in the Schedule of Assessments.
Additionally, efficacy will be assessed by overall survival.
Pharmacokinetic: Plasma concentrations of rovalpituzumab tesirine ADC and the presence of antitherapeutic antibodies (ATA) will be determined.
Biomarkers: Pharmacodynamic and predictive biomarker assessments will include analyses of tumor
material and circulating tumor cells for DLL3 expression, blood samples for inflammatory, tumor, and
soluble markers. Samples may also be used for other nucleic acid or protein based exploratory
biomarkers to understand the sensitivity or resistance to rovalpituzumab tesirine and biology of SCLC.
Safety: Safety assessments include physical exam, vital signs, body weight, ECOG score, clinical
adverse events, laboratory tests (hematology, serum chemistries, urinalysis, and coagulation), ECGs,
echocardiogram, fluid retention questionnaire, radiographic images review for fluid retention, and
monitoring of concomitant medications.
Patient Reported Outcome (PRO):
Changes in the patient reported outcomes (PROs) EORTC QLQ-C30, EORTC QLQ-LC13, and
EQ-5D-5L from baseline will be assessed.

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Participants must have adequate bone marrow, renal and hepatic function
Availability of archived or representative tumor material for assessment of DLL3 expression

Exclusion Criteria

Exclusion Criteria:

Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    740 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