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Trial record 1 of 1 for:    checkmate 73L | NSCLC
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A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 NSCLC That is Unable or Not Planned to be Removed by Surgery (CheckMate73L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026412
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary purpose of the study is to compare the effectiveness of nivolumab + CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Nivolumab Drug: Ipilimumab Drug: Durvalumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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 20, 2019
Estimated Primary Completion Date : October 11, 2023
Estimated Study Completion Date : April 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arms A Drug: Nivolumab
Specified dose on specified days

Drug: Ipilimumab
Q6W in maintenance period in Arm A

Experimental: Arms B Drug: Nivolumab
Specified dose on specified days

Experimental: Arms C Drug: Durvalumab
Q2W in maintenance in Arm C




Primary Outcome Measures :
  1. Progression Free Survival (PFS) Assessed 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. Overall Survival (OS) for Arm B and Arm C [ Time Frame: Up to 55 months ]
  2. Progression Free Survival (PFS) Assessed as per BICR for Arm B and Arm C [ Time Frame: Up to 40 months ]
  3. Objective Response Rate (ORR) and Complete Response Rate Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  4. Duration of Response (DOR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  5. Time to Response (TTR) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  6. Time to Death or Distant Metastases (TTDM) Assessed as per BICR [ Time Frame: Up to 7.5 years ]
  7. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and select AEs [ Time Frame: Up to 2 years ]
  8. Percentage of Participants Without Meaningful Symptom Deterioration Following 48 Weeks of Maintenance Therapy Based on Lung Cancer Subscale (LCS) of FACT-L and NSCLC-SAQ [ Time Frame: 48 Weeks ]


Information from the National Library of Medicine

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

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.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Active infection requiring systemic therapy within 14 days prior to randomization.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured,
  • Participants with an active, known or suspected autoimmune disease or a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of randomization.
  • History of organ or tissue transplant that requires systemic use of immune suppressive agents.
  • Clinical evidence of hearing loss and prior thoracic radiotherapy.

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026412


Contacts
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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 #.

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Locations
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United States, California
Local Institution Not yet recruiting
La Jolla, California, United States, 92037
Contact: Site 0119         
Local Institution Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Site 0111         
United States, Colorado
Local Institution Not yet recruiting
Denver, Colorado, United States, 80218
Contact: Site 0129         
United States, Florida
Local Institution Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Site 0118         
Sacred Heart Medical Oncology Group Recruiting
Pensacola, Florida, United States, 32504
Contact: James Watkins, Site 0039    850-416-6316      
United States, Georgia
Local Institution Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Site 0125         
United States, Kansas
Local Institution Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: Site 0128         
United States, Maryland
Local Institution Not yet recruiting
Bethesda, Maryland, United States, 20817
Contact: Site 0108         
United States, Michigan
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Site 0046         
Local Institution Not yet recruiting
Traverse City, Michigan, United States, 49684
Contact: Site 0116         
United States, Ohio
Local Institution Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: Site 0053         
Local Institution Not yet recruiting
Cincinnati, Ohio, United States, 45236
Contact: Site 0131         
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44106-5055
Contact: Site 0124         
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Site 0112         
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Site 0047         
Local Institution Not yet recruiting
Youngstown, Ohio, United States, 44501
Contact: Site 0123         
United States, South Carolina
Charleston Hematology Oncology Associates, Pa Recruiting
Charleston, South Carolina, United States, 29414
Contact: Gene Saylors, Site 0077         
United States, Texas
CHI St. Joseph Cancer Center Recruiting
Bryan, Texas, United States, 77802
Contact: Mark Floyd, Site 0079         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75203
Contact: Site 0130         
United States, Vermont
Local Institution Not yet recruiting
Burlington, Vermont, United States, 05405
Contact: Site 0071         
Argentina
Local Institution Not yet recruiting
Rio Cuarto, Cordoba, Argentina, 5800
Contact: Site 0045         
Local Institution Not yet recruiting
Caba, Argentina, 1199
Contact: Site 0043         
Local Institution Not yet recruiting
Caba, Argentina, C1426ANZ
Contact: Site 0044         
Local Institution Not yet recruiting
Cuiudad Autonoma De Buenos Aires, Argentina, C1430EGF
Contact: Site 0042         
Local Institution Not yet recruiting
La Rioja, Argentina, 5300
Contact: Site 0055         
Australia, New South Wales
Local Institution Not yet recruiting
Gosford, New South Wales, Australia, 2250
Contact: Site 0134         
Local Institution Not yet recruiting
Kingswood, New South Wales, Australia, 2747
Contact: Site 0033         
Local Institution Not yet recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Site 0113         
Australia, South Australia
Local Institution Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 0028         
Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0052         
Australia
Local Institution Not yet recruiting
Darlinghurst, Australia, 2010
Contact: Site 0031         
Local Institution Not yet recruiting
Greenslopes, Australia, 4120
Contact: Site 0029         
Local Institution Not yet recruiting
Murdoch, Australia, 6150
Contact: Site 0030         
Belgium
Local Institution Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Site 0003         
Local Institution Recruiting
Gent, Belgium, 9000
Contact: Site 0001         
Local Institution Not yet recruiting
Liege, Belgium, 4000
Contact: Site 0004         
Local Institution Not yet recruiting
Yvoir, Belgium, 5530
Contact: Site 0002         
Brazil
Local Institution Not yet recruiting
Ipatinga, Minas Gerais, Brazil, 35162-189
Contact: Site 0038         
Local Institution Not yet recruiting
Porto Alegre - Rs, RIO Grande DO SUL, Brazil, 92350-200
Contact: Site 0034         
Local Institution Not yet recruiting
Blumenau, Santa Catarina, Brazil, 89010-340
Contact: Site 0037         
Local Institution Not yet recruiting
Barretos, SAO Paulo, Brazil, 14780-070
Contact: Site 0036         
Local Institution Not yet recruiting
Rio de Janeiro, Brazil, 20230-130
Contact: Site 0035         
Canada, Ontario
Local Institution Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Site 0127         
Local Institution Not yet recruiting
London, Ontario, Canada, N6A 4L6
Contact: Site 0110         
Local Institution Not yet recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Site 0078         
Local Institution Not yet recruiting
Windsor, Ontario, Canada, N8W 2X3
Contact: Site 0093         
Canada, Quebec
Local Institution Not yet recruiting
Rimouski, Quebec, Canada, G5L 5T1
Contact: Site 0070         
Local Institution Not yet recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9
Contact: Site 0092         
Canada
Local Institution Not yet recruiting
Quebec, Canada, G1V 4G5
Contact: Site 0126         
Chile
Local Institution Not yet recruiting
Santiago de Chile, Metropolitana, Chile
Contact: Site 0041         
Local Institution Not yet recruiting
Vina del Mar, Valparaiso, Chile, 2520598
Contact: Site 0040         
France
Local Institution Not yet recruiting
Bordeaux, France, 33076
Contact: Site 0086         
Local Institution Not yet recruiting
Dijon, France, 21000
Contact: Site 0087         
Local Institution Not yet recruiting
Lyon Cedex 08, France, 69373
Contact: Site 0081         
Local Institution Not yet recruiting
Montpellier, France, 34070
Contact: Site 0082         
Local Institution Not yet recruiting
Nantes Cedex 1, France, 44093
Contact: Site 0084         
Local Institution Not yet recruiting
Paris, France, 75014
Contact: Site 0090         
Germany
Local Institution Not yet recruiting
Berlin, Germany, 14165
Contact: Site 0060         
Local Institution Not yet recruiting
Essen, Germany, 45136
Contact: Site 0063         
Local Institution Not yet recruiting
Gerlingen, Germany, 70839
Contact: Site 0072         
Local Institution Not yet recruiting
Grosshansdorf, Germany, 22927
Contact: Site 0076         
Local Institution Not yet recruiting
Hamm, Germany, 59063
Contact: Site 0101         
Local Institution Not yet recruiting
Heidelberg, Germany, 69126
Contact: Site 0073         
Local Institution Not yet recruiting
Immenhausen, Germany, 34376
Contact: Site 0061         
Local Institution Not yet recruiting
Kempten, Germany, 87439
Contact: Site 0062         
Local Institution Not yet recruiting
Loewenstein, Germany, 74245
Contact: Site 0075         
Local Institution Not yet recruiting
Mainz, Germany, 55101
Contact: Site 0109         
Greece
Local Institution Not yet recruiting
Athens, Greece, 11527
Contact: Site 0135         
Local Institution Not yet recruiting
Larissa, Greece
Contact: Site 0136         
Ireland
Local Institution Not yet recruiting
Dublin 8, Dublin, Ireland
Contact: Site 0024         
Local Institution Not yet recruiting
Dublin, Ireland, D04 Y8V0
Contact: Site 0023         
Italy
Local Institution Not yet recruiting
Brescia, Italy, 25123
Contact: Site 0068         
Local Institution Not yet recruiting
Catania, Italy, 95123
Contact: Site 0049         
Local Institution Not yet recruiting
Catanzaro, Italy, 88100
Contact: Site 0051         
Local Institution Not yet recruiting
Lucca, Italy, 55100
Contact: Site 0050         
Local Institution Not yet recruiting
Perugia, Italy, 06132
Contact: Site 0048         
Korea, Republic of
Local Institution Not yet recruiting
Cheongju-si, Chungcheonbuk-do,, Korea, Republic of, 361-711
Contact: Site 0167         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Site 0152         
Mexico
Local Institution Not yet recruiting
La Paz, BAJA Californa SUR, Mexico, 23040
Contact: Site 0027         
Local Institution Not yet recruiting
Df, Distrito Federal, Mexico, 06720
Contact: Site 0067         
Local Institution Not yet recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Site 0080         
Local Institution Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64060
Contact: Site 0014         
Local Institution Not yet recruiting
Culiacan, Sinaloa, Mexico, 80230
Contact: Site 0015         
Netherlands
Local Institution Not yet recruiting
Amsterdam, Netherlands, 1081HV
Contact: Site 0006         
Local Institution Not yet recruiting
Arnhem, Netherlands, 6815 AD
Contact: Site 0025         
Local Institution Not yet recruiting
Maastrict, Netherlands, 6229 HX
Contact: Site 0005         
Local Institution Not yet recruiting
Veldhoven, Netherlands, 5504 DB
Contact: Site 0026         
Poland
Local Institution Recruiting
Bydgoszcz, Poland, 85-796
Contact: Site 0107         
Klinika Onkologii i Radioterapii Recruiting
Gdansk, Poland, 80-214
Contact: Krzysztof Konopa, Site 0102    +48585844415 00 000 00 00      
Local Institution Not yet recruiting
Krakow, Poland, 31-826
Contact: Site 0104         
Puerto Rico
Puerto Rico Medical Research Center Recruiting
Hato Rey, Puerto Rico, 00917
Contact: Rafael Betancourt-Garcia, Site 0120         
Local Institution Not yet recruiting
San Juan, Puerto Rico, 917
Contact: Site 0132         
Romania
Local Institution Not yet recruiting
Bucharest, Romania, 022328
Contact: Site 0018         
Local Institution Not yet recruiting
Cluj-Napoca, Romania, 400015
Contact: Site 0019         
Local Institution Not yet recruiting
Constanta, Romania, 900591
Contact: Site 0020         
Local Institution Not yet recruiting
Craiova, Romania, 200347
Contact: Site 0017         
Local Institution Not yet recruiting
Floresti, Romania, 407280
Contact: Site 0021         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08025
Contact: Site 0106         
Local Institution Not yet recruiting
Hospitalet de Llobregat, Spain, 08907
Contact: Site 0099         
Local Institution Not yet recruiting
Madrid, Spain, 28007
Contact: Site 0096         
Local Institution Not yet recruiting
Madrid, Spain, 28027
Contact: Site 0098         
Local Institution Not yet recruiting
Madrid, Spain, 28046
Contact: Site 0095         
Local Institution Not yet recruiting
Santiago Compostela, Spain, 15706
Contact: Site 0105         
Local Institution Not yet recruiting
Sevilla, Spain, 41013
Contact: Site 0097         
Local Institution Not yet recruiting
Zaragoza, Spain, 50009
Contact: Site 0100         
Sweden
Local Institution Not yet recruiting
Goteborg, Sweden, 41345
Contact: Site 0065         
Local Institution Not yet recruiting
Solna, Sweden, 17176
Contact: Site 0064         
Switzerland
Local Institution Not yet recruiting
Basel, Switzerland, 4031
Contact: Site 0057         
Local Institution Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Site 0058         
Local Institution Not yet recruiting
St.Gallen, Switzerland, 9007
Contact: Site 0059         
Local Institution Not yet recruiting
Zurich, Switzerland, 8091
Contact: Site 0056         
United Kingdom
Local Institution Not yet recruiting
Poole, Dorset, United Kingdom, BH15 2JB
Contact: Site 0010         
Local Institution Not yet recruiting
Swansea, Glamorgan, United Kingdom, SA2 8QA
Contact: Site 0012         
Local Institution Not yet recruiting
London, Greater London, United Kingdom, N18 1QX
Contact: Site 0011         
Local Institution Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Site 0054         
Local Institution Recruiting
Cottingham, United Kingdom, HU16 5JQ
Contact: Site 0009         
Local Institution Not yet recruiting
Wirral, United Kingdom, CH63 4JY
Contact: Site 0007         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04026412     History of Changes
Other Study ID Numbers: CA209-73L
2019-001222-98 ( EudraCT Number )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Ipilimumab
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents