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A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215706
Recruitment Status : Active, not recruiting
First Posted : July 12, 2017
Results First Posted : September 16, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Biological: Ipilimumab Biological: Nivolumab Drug: Carboplatin Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 719 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : August 16, 2019
Estimated Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Module A
Chemotherapy/Biologics combined
Biological: Ipilimumab
Specified dose on specified day
Other Name: Yervoy, BMS734016

Biological: Nivolumab
Specified dose on specified day
Other Name: Opdivo, BMS936558

Drug: Carboplatin
Specified dose on specified day

Drug: Paclitaxel
Specified dose on specified day
Other Name: Taxol

Drug: Pemetrexed
Specified dose on specified day
Other Name: Alimta

Drug: Cisplatin
Specified dose on specified day
Other Name: Platinol

Active Comparator: Module B
Chemotherapy Combination
Drug: Carboplatin
Specified dose on specified day

Drug: Paclitaxel
Specified dose on specified day
Other Name: Taxol

Drug: Pemetrexed
Specified dose on specified day
Other Name: Alimta

Drug: Cisplatin
Specified dose on specified day
Other Name: Platinol




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months) ]
    OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) by BICR [ Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months) ]
    PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.

  2. Objective Response Rate (ORR) by BICR [ Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months) ]
    ORR was defined as the number of randomized participants with a best overall response (BOR) of confirmed CR or PR based on BICR assessments (using RECIST v1.1 criteria), divided by the number of all randomized participants. BOR was recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of initiation of palliative local therapy or the date of initiation of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or palliative local therapy or subsequent anti-cancer therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial RECIST 1.1 defined progression.

  3. Duration of Response (DoR) [ Time Frame: From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months) ]
    DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.

  4. Time to Response (TTR) [ Time Frame: From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months) ]
    TTR was defined as the time from randomization to the date of the first confirmed documented response (CR or PR), as assessed by the BICR. TTR was evaluated for responders (confirmed CR or PR) only.

  5. Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression [ Time Frame: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to October 2019, approximately 23 months) ]
    PD-L1 expression was defined as the percent of tumor cells with membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC 28-8 pharmDx test. PD-L1 expression was classified as PD-L1 ≥1% (≥1% tumor cells with membrane staining in a minimum of a hundred evaluable tumor cells), PD-L1 < 1% and PD-L1 not quantifiable (without quantifiable PD-L1 expression), PD-L1 expression ≥ 50%, PD-L1 expression 1 to 49%

  6. PFS by BICR by PD-L1 Tumor Cell Expression [ Time Frame: From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2019, approximately 23 months) ]
    PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.

  7. OS by PD-L1 Tumor Cell Expression [ Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months) ]
    OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
  • Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

  • Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
  • Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
  • Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment

Other protocol inclusion/exclusion criteria may 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): NCT03215706


Locations
Hide Hide 116 study locations
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United States, Colorado
Memorial Health Systems
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Cancer Center Of Central Connecticut
Plainville, Connecticut, United States, 06062
United States, Florida
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
United States, Georgia
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, United States, 30060
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Broome Oncology
Johnson City, New York, United States, 13790
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
West Penn Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston Hematology Oncology Associates, Pa
Charleston, South Carolina, United States, 29414
United States, Utah
Southwest Regional Cancer Clinic
Saint George, Utah, United States, 84770
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Argentina
Instituto Alexander Fleming
Caba, Buenos Aires, Argentina, 1426
Instituto Medico Rio Cuarto S.A.
Rio Cuarto, Cordoba, Argentina, 5800
Clinica Viedma S.A.
Viedma, RIO Negro, Argentina, 8500
Sanatorio Parque
Rosario, Santa FE, Argentina, 2000
Instituto Oncologico De Cordoba
Cordoba, Argentina, 5000
Australia, New South Wales
Local Institution
Gosford, New South Wales, Australia, 2250
Australia, South Australia
Local Institution
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Local Institution
Box Hill, Victoria, Australia, 3128
Local Institution
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia, 6150
Belgium
Local Institution
Charleroi, Belgium, 6000
Local Institution
Leuven, Belgium, 3000
Local Institution
Roeselare, Belgium, 8800
Brazil
Local Institution
Natal, RIO Grande DO Norte, Brazil, 59075-740
Local Institution
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 91350-200
Local Institution
Blumenau, Santa Catarina, Brazil, 89010-340
Local Institution
Barretos, SAO Paulo, Brazil, 14780-070
Local Institution
Sao Jose De Rio Preto, SAO Paulo, Brazil, 15091-000
Local Institution
Rio De Janeiro, Brazil, 20231-050
Local Institution
Sao Paulo, Brazil, 01323-020
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Mcgill University Health Center - Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Chile
Centro de Investigacion Clinica Bradford Hill
Santiago de Chile, Metropolitana, Chile
Fundacion Arturo Lopez Perez
Santiago, Metropolitana, Chile
Hospital Clinico Vina Del Mar
Vina Del Mar, Valparaiso, Chile, 2520612
China, Beijing
Local Institution
Beijing, Beijing, China, 100036
China, Henan
Local Institution
Zhengzhou, Henan, China, 450003
Local Institution
Zhengzhou, Henan, China, 450052
China, Hunan
Local Institution
Changsha, Hunan, China, 410000
China, Jilin
Local Institution
Changchun, Jilin, China, 130012
China, Shan3xi
Local Institution
Xi'an, Shan3xi, China, 710038
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200030
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310016
Local Institution
Hangzhou, Zhejiang, China, 310022
China
Local Institution
Beijing, China, 102206
Local Institution
Haikou, China, 570311
France
Local Institution
Caen, France, 14000
Local Institution
Lille Cedex, France, 59037
Centre Leon Berard
Lyon Cedex 08, France, 69373
Local Institution
Montpellier Cedex, France, 34295
Local Institution
Nantes, France, 44093
Local Institution
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Hospitalier De Saint-Brieuc Hopital Yves Le Foll
Saint-Brieuc, France, 22027
Germany
Local Institution
Berlin, Germany, 14165
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany, 82131
Klinik Schillerhoehe GmbH
Gerlingen, Germany, 70839
LungenClinic Grosshansdorf GmbH
Grosshansdorf, Germany, 22927
Lungenklinik Hemer
Hemer, Germany, 58675
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Universitaetsklinikum Magdeburg
Magdeburg, Germany, 39120
Muenchen Klinik - Bogenhausen
Muenchen, Germany, 81925
Ireland
Local Institution
Dublin, Ireland, 8
Local Institution
Limerick, Ireland
Italy
Ospedale San Luca
Lucca, Italy, 55100
Irccs Ospedale S. Raffaele
Milano, Italy, 20132
Azienda Ospedaliera Monaldi
Napol, Italy, 80131
Japan
Local Institution
Fukushima-shi, Fukushima, Japan, 9601295
Local Institution
Maebashi-shi, Gunma, Japan, 3718511
Local Institution
Ota-shi, Gunma, Japan, 3738550
Local Institution
Hiroshima-shi, Hiroshima, Japan, 7308518
Local Institution
Hiroshima-shi, Hiroshima, Japan, 7348511
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Akashi-shi, Hyogo, Japan, 6738558
Local Institution
Himeji-shi, Hyogo, Japan, 6708520
Local Institution
Kobe-shi, Hyogo, Japan, 6500047
Local Institution
Kanazawa-shi, Ishikawa, Japan, 9208641
Local Institution
Shiwa-gun, Iwate, Japan, 0283695
Local Institution
Yokohama-Shi, Kanagawa, Japan, 2360051
Local Institution
Yokohama-shi, Kanagawa, Japan, 2408555
Local Institution
Yokohama-shi, Kanagawa, Japan, 2418515
Local Institution
Niigata-shi, Niigata, Japan, 9518566
Local Institution
Okayama-shi, Okayama, Japan, 7008558
Local Institution
Habikino-shi, Osaka, Japan, 5838588
Local Institution
Osaka-sayama-shi, Osaka, Japan, 5898511
Local Institution
Osaka-shi, Osaka, Japan, 5458586
Local Institution
Kitaadachi-gun, Saitama, Japan, 3620806
Local Institution
Ube-shi, Yamaguchi, Japan, 7550241
Mexico
Oncotech
La Paz, BAJA Californa SUR, Mexico, 23040
Local Institution
Guadalajara, Jalisco, Mexico, 44280
Faicic S. de Rl. de Cv
Veracruz, Veracruz, Mexico, 91900
Poland
Ambulatorium Chemioterapii
Bydgoszcz, Poland, 85-796
Oddzial Onkologii
Bytom, Poland, 41-902
Local Institution
Gdansk, Poland, 80-214
Romania
Local Institution
Bucharest, Romania, 020122
Local Institution
Cluj-Napoca, Romania, 400015
Local Institution
Craiova, Romania, 200347
Russian Federation
Local Institution
Moscow, Russian Federation, 115478
Local Institution
St.petersburg, Russian Federation, 197758
Spain
Comp. Hosp. Univ. A Coruna
A Coru?a, Spain, 15006
H. Univ. Vall dHebron
Barcelona, Spain, 08035
Hosp Univer 12 De Octubre
Madrid, Spain, 28041
Hospital Carlos Haya De Malaga
Malaga, Spain, 29010
Hospital Universitario La Fe
Valencia, Spain, 46026
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE1 9RT
Local Institution
Guildford, United Kingdom, GU2 7XX
Local Institution
Tauton, United Kingdom, TA1 5DA
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] May 10, 2017
Statistical Analysis Plan  [PDF] August 6, 2019

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03215706    
Other Study ID Numbers: CA209-9LA
2017-001195-35 ( EudraCT Number )
First Posted: July 12, 2017    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020

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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
Paclitaxel
Carboplatin
Nivolumab
Pemetrexed
Ipilimumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors