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Non-small Cell Lung CancerPhase 2NCT03840902

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing M7824, Durvalumab and Etoposide in people with Non-small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 104 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
M7824, Durvalumab and Etoposide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
104 sitesin 15 countries
Study dates
16 Apr 2019to 17 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS-1 rearrangement are eligible.
  • Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of predicted normal volume measured within 3 weeks prior to randomization.
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

Who cannot join

  • Participants with Mixed small cell with non-small cell lung cancer histology
  • Recent major surgery within 4 weeks prior to entry into the study
  • Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
  • Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
  • Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins

Trial locations and contacts

104 sites in 15 countries.

104 sites in 15 countries

United States21 sites

  • University of Maryland - DUPLICATE/Pediatric Surgery

    Baltimore, Maryland, 21201

  • Lynn Cancer Institute Center

    Boca Raton, Florida, 33486

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Colorado Health - Memorial Hospital - Memorial Hospital

    Colorado Springs, Colorado, 80909

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Hematology Oncology Associates

    Fort Collins, Colorado, 80528

  • Holy Cross Hospital - Michael and Dianne Bienes CCC

    Fort Lauderdale, Florida, 33308

  • University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

    Houston, Texas, 77030

  • American Health Network of Indiana, LLC

    Indianapolis, Indiana, 46202

  • Franciscan St. Francis Health Cancer Center

    Indianapolis, Indiana, 46237

  • Baptist Health Lexington Oncology Associates

    Lexington, Kentucky, 40503

  • Sylvester Comprehensive Cancer Center - University of Miami Health System

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University Medical Center

    New York, New York, 10032

  • Hematology Oncology Center of Nyack Hospital

    Nyack, New York, 10960

  • University of California Irvine Medical Center

    Orange, California, 92868

  • FirstHealth of the Carolinas, Inc.

    Pinehurst, North Carolina, 28374

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • UCLA Hematology Oncology - Main Site - 2020 Santa Monica

    Santa Monica, California, 90404

Other trials in United States

Spain18 sites

  • Hospital del Mar - Servicio de Oncologia

    Barcelona

  • Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

    Barcelona

  • Hospital Universitari Vall d'Hebron - Dept of Oncology

    Barcelona

  • ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    L'Hospitalet de Llobregat

  • Clinica Universidad de Navarra (MAD) - Oncology Service

    Madrid

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid

  • Hospital Universitario Clinico San Carlos - Servicio de Oncologia

    Madrid

  • Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Hospital Regional Universitario de Malaga

    Málaga

  • Clinica Universidad de Navarra

    Pamplona

  • Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica

    Santiago de Compostela

  • Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia

    Seville

  • Hospital Universitario Virgen del Rocio - Servicio de Oncologia

    Seville

  • Hospital Universitario Virgen Macarena - Servicio de Oncologia

    Seville

  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

    Valencia

  • Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

    Valencia

  • Hospital Alvaro Cunqueiro - Servicio de Oncologia

    Vigo

Other trials in Spain

Japan12 sites

  • Nippon Medical School Hospital - Dept of Respiratory Medicine

    Bunkyō City

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine

    Bunkyō City

  • Saitama Medical University International Medical Center - Dept of Respiratory Medicine

    Hidaka-shi

  • National Cancer Center Hospital East - Dept of Respiratory Medicine

    Kashiwa-shi

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine

    Kobe

  • Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

    Kōtoku

  • Kurume University Hospital - Dept of Lung Cancer Center

    Kurume-shi

  • Aichi Cancer Center Hospital - Dept of Respiratory Medicine

    Nagoya

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka

  • Kindai University Hospital (13859)

    Osakasayama-shi

  • Shizuoka Cancer Center

    Sunto-gun

  • Kanagawa Cancer Center - Dept of Respiratory Medicine

    Yokohama

Other trials in Japan

Australia11 sites

  • Bendigo Hospital

    Bendigo

  • The Townsville Hospital

    Douglas

  • Calvary Central Districts Hospital

    Elizabeth Vale

  • St Vincent's Hospital Melbourne - PARENT

    Fitzroy

  • University Hospital Geelong - PARENT

    Geelong

  • Austin Health

    Heidelberg Heights

  • Centro de Investigacion Pergamino SA

    Pergamino

  • Prince of Wales Hospital

    Randwick

  • Sunshine Hospital

    St Albans

  • Royal North Shore Hospital

    St Leonards

  • South West Healthcare - South West Oncology

    Warrnambool

Other trials in Australia

Netherlands8 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Meander Medisch Centrum - Dep of Pulmonology

    Amersfoort

  • Amphia Ziekenhuis - PARENT - Parent

    Breda

  • Martini ziekenhuis

    Groningen

  • Ziekenhuis St. Jansdal

    Harderwijk

  • St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein

    Nieuwegein

  • St. Elisabeth Ziekenhuis - Parent

    Tilburg

  • ISALA Klinieken Locatie Sophia

    Zwolle

Other trials in Netherlands

Brazil7 sites

  • Hospital de Câncer de Barretos - Fundação Pio XII

    Barretos

  • Clínica de Neoplasias Litoral Ltda.

    Itajaí

  • HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

    Porto Alegre

  • Hospital São Lucas da PUCRS

    Porto Alegre

  • COI - Clínicas Oncológicas Integradas

    Rio de Janeiro

  • A. C. Camargo Cancer Center - Fundação Antônio Prudente

    São Paulo

  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo

Other trials in Brazil

South Korea6 sites

  • Keimyung University Dongsan Hospital

    Daegu

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Severance Hospital, Yonsei University

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

Belgium4 sites

  • UZ Leuven

    Leuven

  • Clinique et Maternite St Elisabeth Namur

    Namur

  • AZ Delta

    Roeselare

  • CHU Mont-Godinne

    Yvoir

Other trials in Belgium

France4 sites

  • Centre Hospitalier de la Côte Basque - Service de Pneumologie

    Bayonne

  • Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

    Marseille

  • Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale

    Paris

  • CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

    Saint-Herblain

Other trials in France

Taiwan4 sites

  • Taichung Veterans General Hospital

    Taichung

  • Chi Mei Medical Center, Liou Ying

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

China3 sites

  • Peking University Cancer Hospital

    Beijing

  • Jilin Cancer Hospital - Oncology

    Changchun

  • Hangzhou First People's Hospital

    Hangzhou

Other trials in China

Argentina2 sites

  • Sanatorio Allende

    Córdoba

  • Centro Polivalente de Asistencia e Inv. Clinica CER

    San Juan

Other trials in Argentina

Germany2 sites

  • Asklepios Klinik Harburg - Medizinische Abteilung I

    Hamburg

  • Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

    Oldenburg

Other trials in Germany

Canada1 site

  • BC Cancer Agency Center for the Southern Interior

    Kelowna

Other trials in Canada

Czechia1 site

  • Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

    Olomouc

Other trials in Czechia

About this study

Official title: 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

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Being tested
M7824, Placebo, Durvalumab, Etoposide, Pemetrexed
Keywords
Non-small Cell Lung Cancer, Bintrafusp alfa (proposed INN), M7824, Durvalumab, Stage III, INTR@PID LUNG 005
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M7824Drug

    Participants received intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

  • PlaceboDrug

    Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

  • DurvalumabDrug

    Participants received intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

  • EtoposideDrug

    Participants received etoposide 50 mg/m^2 intravenously over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT.

  • PemetrexedDrug

    Participants received pemetrexed at a dose of 500 mg/m^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT.

  • CarboplatinDrug

    Participants received carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.

  • PaclitaxelDrug

    Participants received paclitaxel intravenously at a dose of 45 mg/m^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.

  • CisplatinDrug

    In combination with etoposide, participants received cisplatin 50 mg/m^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.

  • Intensity Modulated Radiation Therapy (IMRT)Radiation

    Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray [Gy]).

Study groups in NCT03840902
Study groupRoleWhat they receive
cCRT plus M7824 followed by M7824ExperimentalParticipants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
Receives: Drug: M7824; Drug: Etoposide; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT)
cCRT plus placebo followed by durvalumabActive comparatorParticipants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.
Receives: Drug: Placebo; Drug: Durvalumab; Drug: Etoposide; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy (IMRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

    PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.

    Measured: Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months

Secondary outcomes (7)

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events

    Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.

    Measured: Time from randomization up to data cut off (assessed up to 27 months)

  2. Overall Survival (OS)

    Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

    Measured: Time from randomization to the date of death due to any cause, assessed up to 27 months

  3. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

    ORR was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to RECIST v1.1as adjudicated by the Investigator. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: Time from randomization up to data cut off (assessed up to 27 months)

  4. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

    DOR was defined as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

    Measured: Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months

  5. Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824

    Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed M7824 concentration-time data.

    Measured: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343

  6. Serum Concentration Immediately Before Next Dosing (Ctrough) of M7824

    Ctrough was the serum concentration observed immediately before next dosing.

    Measured: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343

  7. Number of Participants With Positive Antidrug Antibodies (ADA)

    Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.

    Measured: Time from randomization up to data cut off (assessed up to 27 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start16 Apr 2019
  3. Primary completion17 Feb 2023
  4. Study completion17 Feb 2023

Why it stopped: Based on recommendations by an external Independent data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840902
Sponsor's protocol ID
MS200647_0005
Other IDs
2018-003265-34, 2018
Status last verified
Jan 2024
First submitted
12 Feb 2019
Last updated
16 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

  • Huang Y, Zhao JJ, Soon YY, Wong A, Aminkeng F, Ang Y, Asokumaran Y, Low JL, Lee M, Choo JRE, Chan G, Kee A, Tay SH, Goh BC, Soo RA. Real-world experience of consolidation durvalumab after concurrent chemoradiotherapy in stage III non-small cell lung cancer. Thorac Cancer. 2022 Nov;13(22):3152-3161. doi: 10.1111/1759-7714.14667. Epub 2022 Sep 30.

    PubMed 36177913

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M7824, Durvalumab and Etoposide in people with Non-small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 104 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Spain, Japan, Australia, Netherlands and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator (time frame: Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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