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Clinical Trials List

Protocol NumberEMR 100070-005
NCT Number(ClinicalTrials.gov Identfier)NCT02576574

2015-10-01 - 2022-06-22

Phase III

Terminated7

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non–small-cell lung cancer

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    EMD Serono Research & Development Institute, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator CHIN-CHOU WANG 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator James Chih-Hsin Yang 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yuh-Min Chen 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Te-Chun Hsia 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Gee-chen Chang 無
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Cheng-Ta Yang 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Non-Small Cell Lung Cancer (NSCLC)

Objectives

Primary Objectives The primary objective is to demonstrate superiority with regard to PFS, as determined by an independent review committee according to RECIST 1.1 of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+ (as determined by a Dako PD-L1 IHC pharmDx companion diagnostic test under development). Secondary Objectives Secondary objectives are as follows:  To demonstrate superiority with regard to PFS of avelumab versus chemotherapy in PD-L1++ subjects (at least 25% PD-L1 positive tumor cells with at least 2+ staining intensity)  To demonstrate superiority with regard to the ORR by RECIST 1.1 of avelumab versus chemotherapy in PD-L1+ subjects  To demonstrate superiority with regard to the OS of avelumab versus chemotherapy in PD-L1+ subjects  To compare the subject-reported outcomes / quality of life when treated with avelumab versus chemotherapy using the European Quality of Life (EuroQOL) 5-dimensions questionnaire (EQ-5D), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ-LC13 in the ITT population  To determine the safety and tolerability of avelumab.

Test Drug

Avelumab

Active Ingredient

Avelumab

Dosage Form

Injection

Dosage

20

Endpoints

Primary endpoints:
The primary endpoint for the trial is the PFS, defined as the time from
date of randomization until date of the first documentation of PD as determined by the
independent response committee/radiologist (per RECIST 1.1) or death due to any cause in the
absence of documented PD, whichever occurs first.

Secondary endpoints: The secondary endpoints include:
 PFS time in PD L1++ subjects,
 BOR according to RECIST 1.1 and as adjudicated by the IRC,
 OS time (defined as the time from randomization to the date of death),
 changes in subject-reported outcomes/quality of life (assessed by the EQ-5D, and the
EORTC QLQ-C30, and module QLQ-LC13 questionnaires)
 safety endpoints (including AEs, clinical laboratory assessments, vital signs, physical
examination, electrocardiogram [ECG] parameters, and ECOG PS).

Inclution Criteria

Key inclusion criteria:
Male or female subjects ≥ 18 years, with an ECOG PS of 0 to 1 at trial entry, with the
availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or
7 (preferably 10) unstained tumor slides with PD-L1+, at least 1 measurable tumor lesion, and
with histologically confirmed metastatic or recurrent NSCLC. Subjects must not have received
any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12
weeks.

Exclusion Criteria

Key exclusion criteria:
Subjects whose disease harbors an activating EFGR mutation, or with non-squamous cell
NSCLC whose disease harbors and anaplastic lymphoma kinase (ALK) rearrangement are not
eligible. Other exclusion criteria include prior therapy with any antibody or drug targeting
T-cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents,
known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE
v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially
controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE
v 4.03. Subjects with brain metastases are excluded, except those meeting the following
criteria: brain metastases that have been treated locally and are clinically stable for at least
2 weeks prior to enrollment, subjects must be either off steroids or on a stable or decreasing
dose of <10mg daily prednisone (or equivalent), and do not have ongoing neurological
symptoms that are related to the brain localization of the disease. All potential exceptions must
be discussed with the study Medical Monitor prior to enrollment.

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    1131 participants

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