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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery (CheckMate73L)

  • Clinicaltrials.gov identifier

    NCT04026412

  • Recruitment Status

    Recruiting

  • First Posted

    July 19, 2019

  • Last update posted

    July 26, 2021

Study Description

Brief summary:

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

  • Condition or Disease:Non-Small Cell Lung Cancer (NSCLC)
  • Intervention/Treatment: Biological: nivolumab
    Biological: ipilimumab
    Biological: durvalumab
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 1400 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: November 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: nivolumab + CCRT + ipilimumab
Concurrent chemoradiotherapy (CCRT)
Biological: nivolumab
Specified dose on specified days

Biological: ipilimumab
Specified dose on specified days
Experimental: Arm B: nivolumab + CCRT
Concurrent chemoradiotherapy (CCRT)
Biological: nivolumab
Specified dose on specified days
Experimental: Arm C: CCRT + durvalumab
Concurrent chemoradiotherapy (CCRT)
Biological: durvalumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C [ Time Frame: Up to 5 years ]
  • 2. Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]
  • Secondary Outcome Measures: 1. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C [ Time Frame: Up to 40 months ]
  • 2. Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  • 3. Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B [ Time Frame: Up to 40 months ]
  • 4. Overall Survival (OS) for Arm A and Arm B [ Time Frame: Up to 55 months ]
  • 5. Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • 6. Complete Response Rate (CR rate) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • 7. Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • 8. Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR) [ Time Frame: Up to 7.5 years ]
  • 9. Progression-free survival (PFS) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 40 months ]
  • 10. Objective response rate (ORR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • 11. CR rate by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • 12. DoR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • 13. TTR by RECIST 1.1 per investigator assessment [ Time Frame: Up to 7.5 years ]
  • 14. Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment [ Time Frame: Up to 7.5 years ]
  • 15. Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
  • 16. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  • 17. Proportion of participants without symptom deterioration based on LCS subscale of FACT-L and NSCLC-SAQ [ Time Frame: 48 Weeks ]
    Lung Cancer Subscale (LCS), Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) histologically-confirmed NSCLC, according to 8th TNM classification - Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease Exclusion Criteria: - Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the patient from adhering to the protocol or would increase the risk associated with study participation - Active infection requiring systemic therapy within 14 days prior to randomization - History of organ or tissue transplant that requires systemic use of immune suppressive agents - Prior thoracic radiotherapy Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
La Jolla

United States, California
Local Institution
Palo Alto

United States, California
California Pacific Medical Center
San Francisco

United States, California
Local Institution
San Francisco

United States, Colorado
Rocky Mountain Cancer Centers Llp
Denver

United States, Florida
Local Institution
Jacksonville

United States, Florida
Local Institution
Jacksonville

United States, Florida
Local Institution
Orlando

United States, Florida
Sacred Heart Medical Oncology Group
Pensacola

United States, Georgia
Emory University Hospital
Atlanta

United States, Georgia
Medical College Of Georgia
Augusta

United States, Kansas
Local Institution
Westwood

United States, Kentucky
Local Institution
Edgewood

United States, Maryland
Rcca Md Llc
Bethesda

United States, Michigan
Local Institution
Detroit

United States, Michigan
Munson Medical Center
Traverse City

United States, Ohio
Good Samaritan Hospital
Cincinnati

United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati

United States, Ohio
University Of Cincinnati
Cincinnati

United States, Ohio
Louis Stokes Cleveland VA Medical Center - Wade Park Campus Location
Cleveland

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland

United States, Ohio
MetroHealth Medical Center
Cleveland

United States, Ohio
Mercy Health Youngstown
Youngstown

United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston

United States, Texas
Texas Oncology-Central Austin Cancer Center
Austin

United States, Texas
CHI St. Joseph Cancer Center
Bryan

United States, Texas
Texas Oncology-Methodist Dallas Cancer Center
Dallas

United States, Vermont
University of Vermont Cancer Center
Burlington

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Cordoba
Local Institution
Rio Cuarto

Argentina, Distrito Federal
Local Institution
Buenos Aires

Argentina, Distrito Federal
Local Institution
Cuiudad Autonoma De Buenos Aires

Argentina
Local Institution
La Rioja

Australia, New South Wales
Local Institution
Darlinghurst

Australia, New South Wales
Local Institution
Gosford

Australia, New South Wales
Local Institution
Kingswood

Australia, New South Wales
Local Institution
Port Macquarie

Australia, Queensland
Local Institution
Greenslopes

Australia, South Australia
Local Institution
Adelaide

Australia, Victoria
Local Institution
Ballarat

Australia, Victoria
Local Institution
Melbourne

Australia, Western Australia
Local Institution
Murdoch

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Gent

Belgium
Local Institution
Liege

Belgium
Local Institution
Yvoir

Brazil, Minas Gerais
Local Institution
Ipatinga

Brazil, RIO Grande DO SUL
Local Institution
Ijui

Brazil, Rio Grande Do Sul
Local Institution
Porto Alegre - Rs

Brazil, Santa Catarina
Local Institution
Blumenau

Brazil, Sao Paulo
Local Institution
Barretos

Brazil
Local Institution
Rio de Janeiro

Canada, Ontario
Local Institution
Kingston

Canada, Ontario
Local Institution
London

Canada, Ontario
Local Institution
Oshawa

Canada, Ontario
Local Institution
Windsor

Canada, Quebec
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski

Canada, Quebec
Local Institution
Saguenay

Canada, Quebec
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivieres

Canada
Local Institution
Quebec

Chile, Metropolitana
Local Institution
Santiago de Chile

Chile, Valparaiso
Local Institution
Vina del Mar

China, BEI
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Fujian
Local Institution
Fuzhou

China, Fujian
Local Institution
Xiamen

China, Guizhou
Local Institution
Guiyang

China, Hubei
Local Institution
Hankou

China, Hubei
Local Institution
Wuhan

China, Hubei
Local Institution
Wuhan

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangxi
Local Institution
Nanchang

China, Jilin
Local Institution
Changchun

China, Jilin
Local Institution
Changchun

China, Jilin
Local Institution
Gongzhuling

China, Shandong
Local Institution
Jinan

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Zhejiang
Local Institution
Hangzhou

China, Zhejiang
Local Institution
Linhai

China
Local Institution
Chengdu

France
Institut Bergonie
Bordeaux

France
Centre Georges-Francois Leclerc
Dijon

France
Centre Leon Berard
Lyon

France
Centre de Cancerologie du Grand Montpellier
Montpellier

France
Institut Curie
Paris

France
Hopital Cochin
Paris

France
Hôpital Bichat - Claude-Bernard-Thoracic Oncology
Paris

France
Hopital Tenon
Paris

France
Hopital Nord Laennec Chu De Nantes
Saint Herblain

France
Local Institution
Strasbourg Cedex

France
Hopital Bretonneau
Tours Cedex

Germany
HELIOS Klinikum Emil von Behring
Berlin

Germany
Klinik Essen-Mitte
Essen

Germany
LungenClinic Grosshansdorf GmbH
Grosshansdorf

Germany
Evangelisches Krankenhaus Hamm
Hamm

Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg

Germany
Lungenfachklinik Immenhausen
Immenhausen

Germany
Klinikverbund Kempten-Oberallgau
Kempten

Germany
Klinik Loewenstein gGmbH
Loewenstein

Germany
Universitaetsmedizin Der Johannes Gutenberg-Universitaet
Mainz

Germany
Klinik Schillerhoehe GmbH
Stuttgart

Greece
Local Institution
Athens

Greece
Sotiria General Hospital
Athens

Greece
University General Hospital of Larissa
Larissa

Greece
Agioi Anargyroi Cancer Hospital
Nea Kifisia Athens

Ireland, Dublin
Local Institution
Dublin 8

Ireland
Local Institution
Dublin

Italy
Local Institution
Brescia

Italy
Aou Policlinico V. Emanuele Di Catania
Catania

Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro

Italy
Ospedale San Luca
Lucca

Italy
Local Institution
Milano

Italy
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza

Italy
Local Institution
Perugia

Japan, Aichi
Local Institution
Nagoya

Japan, Fukuoka
Local Institution
Fukuoka-shi

Japan, Fukuoka
Local Institution
Kurume-shi

Japan, Gunma
Local Institution
Ota-shi

Japan, Hokkaido
Local Institution
Sapporo-shi

Japan, Hyogo
Local Institution
Kobe

Japan, Ishikawa
Local Institution
Kanazawa-shi

Japan, Kanagawa
Local Institution
Yokohama-shi

Japan, Kanagawa
Local Institution
Yokohama-Shi

Japan, Kanagawa
Local Institution
Yokohama

Japan, Miyagi
Local Institution
Sendai-shi

Japan, Niigata
Local Institution
Niigata-shi

Japan, Osaka
Local Institution
Osaka-shi

Japan, Osaka
Local Institution
Osakasayama

Japan, Saitama
Local Institution
Hidaka-shi

Japan, Saitama
Local Institution
Kitaadachi-gun

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Chuo-ku

Japan, Wakayama
Local Institution
Wakayama-shi

Japan, Yamaguchi
Local Institution
Ube

Korea, Republic of
Local Institution
Cheongju-si

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, BAJA Californa SUR
Local Institution
La Paz

Mexico, Distrito Federal
Local Institution
Df

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo Leon
Local Institution
Monterrey

Mexico, Sinaloa
Local Institution
Culiacan

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Arnhem

Netherlands
Local Institution
Maastrict

Netherlands
Local Institution
Veldhoven

Poland
Local Institution
Bydgoszcz

Poland
Klinika Onkologii i Radioterapii
Gdansk

Poland
Oddzial Radioterapii
Krakow

Poland
Local Institution
Tomaszow Mazowiecki

Puerto Rico
Puerto Rico Medical Research Center
Hato Rey

Puerto Rico
GCM Medical Group
San Juan

Romania
Local Institution
Bucharest

Romania
Local Institution
Bucuresti

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Constanta

Romania
Local Institution
Craiova

Romania
Local Institution
Floresti

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
St. Petersburg

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
Local Institution
Barcelona

Spain
Local Institution
Hospitalet de Llobregat

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Pamplona

Spain
Local Institution
Santiago Compostela

Spain
Local Institution
Sevilla

Spain
Local Institution
Zaragoza

Sweden
Local Institution
Goteborg

Sweden
Local Institution
Solna

Switzerland
University Hospital Basel
Basel

Switzerland
Centre hospitalier universitaire Vaudois (CHUV)
Lausanne

Switzerland
Kantonsspital St. Gallen
St.Gallen

Switzerland
University Hospital Zuerich
Zuerich

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
New Taipei City

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

United Kingdom, Glamorgan
Local Institution
Swansea

United Kingdom, Greater London
Local Institution
London

United Kingdom
Local Institution
Aberdeen

United Kingdom
Local Institution
Cottingham

United Kingdom
Local Institution
Poole

United Kingdom
Local Institution
Wirral

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04026412 History of Changes
  • Other Study ID Numbers: CA209-73L, 2019-001222-98
  • First Posted: July 19, 2019 Key Record Dates
  • Last Update Posted: July 26, 2021
  • Last Verified: July 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung Lung Neoplasms