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

Clinical Trials List

Protocol NumberMS200647_0005
NCT Number(ClinicalTrials.gov Identfier)NCT03840902

2019-06-01 - 2021-09-28

Phase II

Recruiting5

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

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Merck KGaA

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 簡志峰 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

Primary Objective To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab Secondary Objectives To evaluate the safety in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate OS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate changes in lung function in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate the association of PD-L1 expression at Baseline with efficacy in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate objective tumor response in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate duration of response in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To characterize PK profile of M7824 plus cCRT and after cCRT To characterize the immunogenicity of M7824 plus cCRT and after cCRT

Test Drug

M7824

Active Ingredient

M7824

Dosage Form

Concentrate for solution for infusion

Dosage

10 mg/mL, 60 mL/vial

Endpoints

Primary Outcome Measures :
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Assessed by Independent Review Committee (IRC) [ Time Frame: Time from first dose up to 59 Months ]

Secondary Outcome Measures :
Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs [ Time Frame: Baseline up to 8.8 years ]
Overall Survival [ Time Frame: Baseline up to 8.8 years ]
Changes from Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) [ Time Frame: Baseline up to 14 months ]
Programmed death-ligand 1 (PD-L1) Expression in Tumors Assessed with Immunohistochemistry (IHC) and Association with Efficacy [ Time Frame: Baseline up to 8.8 years ]
Objective Response According to RECIST 1.1 Assessed by IRC [ Time Frame: Baseline up to 8.8 years ]
Duration of Response According to RECIST 1.1 [ Time Frame: Baseline up to 8.8 years ]
Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays [ Time Frame: Baseline up to 8.8 years ]
Concentration Immediately Before Next Dosing (Ctrough) [ Time Frame: Baseline up to 14 months ]
Concentration Immediately at End of Infusion (Ceoi) [ Time Frame: Baseline up to 14 months ]
Changes from Baseline in High-resolution Computed Tomography (HRCT) [ Time Frame: Baseline up to 14 months ]
Changes from Baseline in Forced Expiratory Volume in one Second (FEV1) [ Time Frame: Baseline up to 14 months ]
Changes from Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline up to 14 months ]
Changes from Baseline in 6-minutes Walking Test [ Time Frame: Baseline up to 14 months ]

Inclution Criteria

1. Are ≥ 18 years of age at the time of signing the informed consent. In Japan, if a patient
is < 20 years, the written informed consent from his/her parent or guardian will be required
in addition to the patient’s written consent.
2. Participants must have measurable or non-measurable but evaluable disease assessed by the
Investigator. Participants must have histologically documented NSCLC who present with
Stage III locally advanced, unresectable disease (International Association for the Study of
Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic
Oncology], v8).
3. Availability of tumor material (< 6 months old) adequate for biomarker analysis is
mandatory for all participants and central laboratory confirmation is required. For
participants enrolled in the safety run-in, PD-L1 expression will be tested retrospectively
by a central laboratory. For participants enrolled in the expansion part of the study, PD-L1
expression must be tested by the central laboratory and results available before
randomization. Only results from the central laboratory testing will be used for
randomization and if PD-L1 status is non-evaluable, the participant is not eligible for this
study. Tumor samples obtained by endoscopic biopsies, core needle biopsies, excisional
biopsies, punch biopsies, and surgical specimens that are < 6 months old and adequate for
biomarker analysis are acceptable. Biopsies obtained by fine needle aspiration are not
acceptable.
4. Participants with tumor harboring an EGFR sensitizing (activating) mutation, ALK
translocation, ROS-1 rearrangement are eligible. These tests are not required for enrollment
in the study.
5. Participants with ongoing post-obstructive pneumonia due to the tumor are eligible.
6. If a pleural effusion is present, the following criteria must be met to exclude malignant
involvement (incurable T4 disease):
a. When pleural fluid is visible on both the CT scan and on a chest x-ray, a
thoracentesis is required to confirm that the pleural fluid is cytologically negative.
b. Participants with exudative pleural effusions are excluded, regardless of cytology.
c. Participants with effusions that are minimal, i.e., are too small to safely tap are
eligible.
7. Participants must be at least 3 weeks from prior thoracotomy (if performed).
8. Participants must have adequate pulmonary function defined as a forced expiratory volume
in 1 second (FEV1) ≥ 1.2 liters or ≥ 50% of predicted normal volume measured within
3 weeks prior to randomization. If participants do not meet the above criteria, treatment
with inhaled steroids and bronchodilators can be initiated if clinically indicated and
eligibility can be reassessed after 1-2 weeks.
9. ECOG performance status of 0 to 1 at Screening and on the day of first dose.
10. Life expectancy ≥ 12 weeks.
11. Have adequate organ function as indicated by the following laboratory values
a. Adequate hematological function defined by absolute neutrophil count (ANC)
≥ 1.5 × 109
/L, platelet count ≥ 100 × 109
/L, and hemoglobin ≥ 9 g/dL.
b. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × upper limit of normal
(ULN), an aspartate aminotransferase (AST) level ≤ 3.0 × ULN, an alanine
aminotransferase (ALT) level ≤ 3.0 × ULN and alkaline phosphatase ≤ 2.5 ULN.
c. Adequate renal function defined by creatine ≤ 1.5x ULN or calculated creatinine
clearance (CrCl) ≥ 50 mL/min for participant with Cr > 1.5x ULN (GFR can also be
used). Note: CrCl should be calculated per institutional standard. If no local guideline is
available, CrCl should be calculated using the Cockcroft-Gault Method:
CrCl = ((140-age) * weight (kg) * (0.85 for females only)) / (72 * creatinine)
d. Adequate coagulation function defined as international normalized ratio (INR) or
prothrombin time (PT) ≤ 1.5 X ULN unless the participant is receiving anticoagulant
therapy and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN unless the
participant is receiving anticoagulant therapy.
12. Contraceptive use by males or females will be consistent with local regulations on
contraception methods for those participating in clinical studies.
13. Can give signed informed consent, as indicated in Appendix 2, which includes compliance
with the requirements and restrictions listed in the informed consent form (ICF) and this
protocol.

Exclusion Criteria

1. Mixed small cell with non-small cell lung cancer histology.
2. Greater than minimal, exudative, or cytologically positive pleural effusions.
3. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement
of vascular access) that would prevent administration of study drug.
4. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative
colitis).
5. History of organ transplant that requires therapeutic immunosuppression.
6. Significant acute or chronic infections including, among others:
a. Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (testing at Screening is not required). If an
Investigator has a strong suspicion of HIV infection without known history for a
participant in Screening, however participant refuses testing, discuss with Medical
Monitor to assess eligibility. (Note: HIV testing is not mandated for study inclusion;
however, if it is performed at any point in Screening or while on study, a site must
consent the participant for HIV testing as per local standard guidance.)
b. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface
antigen positive and HBV core antibody positive with reflex to positive HBV DNA, or
HBV core antibody positive alone with reflex to positive HBV DNA, or positive HCV
antibody with reflex to positive HCV RNA) at Baseline. Discuss with the Medical
Monitor if history of HBV or HCV infection is known. If medically indicated,
participants infected with HBV must be treated and on a stable dose of antivirals (e.g,
entecavir, tenofovir, or lamivudine; adefovir or interferon are not allowed) at study entry
and with planned monitoring and management according to appropriate labeling
guidance. Participants on active HCV therapy at study entry must be on a stable dose
without documented clinically significant impaired liver function test or hematologic
abnormalities (must meet criteria above) and with planned monitoring and management
according to appropriate labeling guidance. HBV and/or HCV viral titers must be
monitored according to SoA in these participants.
c. Participants with active tuberculosis (history of exposure or history of positive
tuberculosis test; plus presence of clinical symptoms, physical, or radiographic
findings).
7. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive
heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia,
active peptic ulcer disease or gastritis, active bleeding diatheses, active uveitis or
psychiatric illness/social situations that would limit compliance with study requirements or
compromise the ability of the patient to give written informed consent.
8. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring
hospitalization or precluding study therapy within 30 days before randomization.
9. Known clinical history of tuberculosis, lung sarcoidosis and Interstitial Lung Diseases.
10. History of another primary malignancy within 3 years prior to starting study drug, except
for adequately treated basal or squamous cell carcinoma of the skin, adequately treated
carcinoma in situ, e.g., cancer of the cervix in situ, superficial bladder cancer. History of
other localized malignancies treated with curative intent needs to be discussed with the
Medical Monitor.
11. Uncontrolled neuropathy Grade 2 or greater regardless of cause.
12. Significant hearing loss and participants unwilling to accept potential for further hearing
loss (Investigator should consider treating the participant with carboplatin/paclitaxel).
13. Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug
targeting T-cell coregulatory proteins (immune checkpoints) such as anti-PD-(L)1, or
anti-CTLA-4 antibody.
14. Current or prior use of immunosuppressive medication within 28 days before the first dose
of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic
corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone,
or an equivalent corticosteroid. Systemic steroid administration required to manage
toxicities arising from radiation therapy delivered as part of the cCRT for locally advanced
NSCLC is allowed.
15. Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with
use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), OR is
receiving systemic steroid therapy < 3 days prior to the first dose of study intervention or
receiving any other form of immunosuppressive medication. Participants requiring
hormone replacement with corticosteroids are eligible if the steroids are administered only
for the purpose of hormonal replacement and at low doses (typically ≤ 10 mg of prednisone
or equivalent per day). Equivalent hydrocortisone doses are also permitted if administered
as a replacement therapy. Corticosteroid use on study as a premedication for IV contrast
allergies/reactions (related to scans) is allowed and must be documented. This must be
discussed with Medical Monitors for clinical indications in which participants may require
a higher dose. Active autoimmune disease that might deteriorate when receiving an
immunostimulatory agent. Participants with diabetes Type I, vitiligo, alopecia, psoriasis,
hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Consult Medical Monitor for other autoimmune diseases.
16. Receipt of live attenuated vaccination within 30 days of receiving study drug.
17. Use of a prohibited concomitant drug, as defined in Section 6.5.2 within 4 weeks
randomization.
18. Known severe hypersensitivity (Grade ≥ 3 National Cancer Institute [NCI] Common
Terminology Criteria for Adverse Events [CTCAE] v5.0) to study interventions or any
components in their formulations, or uncontrolled asthma (i.e., 3 or more features of
partially controlled asthma).
19. Participation in another clinical study with an investigational product within the last
4 weeks.
20. Concurrent enrolment in another clinical study, unless it is an observational
(non-interventional) clinical study or the follow-up period of an interventional study.
21. ≥ 10% weight loss within the past month.
22. Female patients who are pregnant, breast-feeding or male or female patients of
reproductive potential who are not employing an effective method of birth control.
23. Any condition that, in the opinion of the Investigator, would interfere with evaluation of
the study drug or interpretation of participant safety or study results.

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    350 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