A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

Non-Small Cell Lung Cancer Clinical Trial

— CheckMate 9LA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03215706
• Other study ID #: CA209-9LA
• Secondary ID: 2017-001195-35
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 24, 2017
• Est. completion date: January 19, 2026

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 719
• Est. completion date: January 19, 2026
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Ipilimumab
Specified dose on specified day
• Nivolumab
Specified dose on specified day

Drug:
• Carboplatin
Specified dose on specified day
• Paclitaxel
Specified dose on specified day
• Pemetrexed
Specified dose on specified day
• Cisplatin
Specified dose on specified day

Locations

Country	Name	City	State
Argentina	Local Institution - 0014	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0030	Cordoba
Argentina	Local Institution - 0028	Rio Cuarto	Cordoba
Argentina	Local Institution - 0027	Rosario	Santa Fe
Argentina	Local Institution - 0026	Viedma	Rio Negro
Australia	Local Institution - 0040	Bedford Park	South Australia
Australia	Local Institution - 0089	Box Hill	Victoria
Australia	Local Institution - 0086	Gosford	New South Wales
Australia	Local Institution - 0036	Heidelberg	Victoria
Australia	Local Institution - 0078	Murdoch	Western Australia
Belgium	Local Institution - 0002	Gilly
Belgium	Local Institution - 0033	Leuven
Belgium	Local Institution - 0001	Roeselare
Brazil	Local Institution - 0064	Barretos	Sao Paulo
Brazil	Local Institution - 0069	Blumenau	Santa Catarina
Brazil	Local Institution - 0063	Ijui	Rio Grande Do Sul
Brazil	Local Institution - 0068	Natal	RIO Grande DO Norte
Brazil	Local Institution - 0067	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 0066	Rio De Janeiro
Brazil	Local Institution - 0065	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Local Institution - 0070	São Paulo
Canada	Local Institution - 0082	Montreal	Quebec
Canada	Local Institution - 0083	Montreal	Quebec
Canada	Local Institution - 0090	Montreal	Quebec
Canada	Local Institution - 0080	Rimouski	Quebec
Chile	Local Institution - 0059	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0084	Santiago	Metropolitana
Chile	Local Institution - 0079	Vina Del Mar	Valparaiso
China	Local Institution - 0113	Beijing
China	Local Institution - 0139	Beijing	BEI
China	Local Institution - 0106	Changchun	Jilin
China	Local Institution - 0144	Changsha	Hunan
China	Local Institution - 0146	Haikou	Hainan
China	Local Institution - 0110	Hangzhou	Zhejiang
China	Local Institution - 0112	Shanghai
China	Local Institution - 0108	Xi'an City	Shan3xi
China	Local Institution - 0111	Zhejiang	Zhejiang
China	Local Institution - 0120	Zhengzhou	Henan
China	Local Institution - 0148	Zhengzhou	Henan
France	Local Institution - 0010	Bron	Rhone Alpes
France	Local Institution - 0013	Caen
France	Local Institution - 0071	Lille Cedex
France	Local Institution - 0009	Lyon Cedex08	Rhône-Alpes
France	Local Institution - 0012	Montpellier
France	Local Institution - 0035	Nantes
France	Local Institution - 0011	Paris Cedex 20
France	Local Institution - 0097	Saint-Brieuc
Germany	Local Institution - 0073	Berlin
Germany	Local Institution - 0016	Gauting
Germany	Local Institution - 0072	Grosshansdorf
Germany	Local Institution - 0019	Hemer
Germany	Local Institution - 0017	Immenhausen
Germany	Local Institution - 0074	Magdeburg
Germany	Local Institution - 0015	Muenchen
Germany	Local Institution - 0018	Yes
Ireland	Local Institution - 0021	Dublin
Ireland	Local Institution - 0020	Limerick
Italy	Ospedale San Luca	Lucca
Italy	Ospedale San Raffaele	Milano
Italy	Local Institution - 0043	Napoli
Japan	Local Institution - 0131	Akashi-shi	Hyogo
Japan	Local Institution - 0101	Fukushima-shi	Fukushima
Japan	Local Institution - 0135	Habikino-shi	Osaka
Japan	Local Institution - 0119	Himeji-shi	Hyogo
Japan	Local Institution - 0137	Hiroshima-shi	Hiroshima
Japan	Local Institution - 0138	Hiroshima-shi	Hiroshima
Japan	Local Institution - 0115	Kanazawa-shi	Ishikawa
Japan	Local Institution - 0102	Kitaadachi-gun	Saitama
Japan	Local Institution - 0104	Kobe-shi	Hyogo
Japan	Local Institution - 0118	Maebashi-shi	Gunma
Japan	Local Institution - 0116	Niigata-shi	Niigata
Japan	Local Institution - 0136	Okayama-shi	Okayama
Japan	Local Institution - 0103	Osaka-sayama-shi	Osaka
Japan	Local Institution - 0130	Osaka-shi	Osaka
Japan	Local Institution - 0128	Ota-shi	Gunma
Japan	Local Institution - 0127	Sapporo-shi	Hokkaido
Japan	Local Institution - 0100	Shiwa-gun	Iwate
Japan	Local Institution - 0132	Ube-shi	Yamaguchi
Japan	Local Institution - 0114	Yokohama-Shi	Kanagawa
Japan	Local Institution - 0129	Yokohama-shi	Kanagawa
Japan	Local Institution - 0134	Yokohama-shi	Kanagawa
Mexico	Local Institution - 0061	Guadalajara	Jalisco
Mexico	Local Institution - 0077	La Paz	BAJA Californa SUR
Mexico	Local Institution - 0075	Veracruz, Veracruz
Poland	Local Institution - 0087	Bydgoszcz
Poland	Local Institution - 0022	Bytom
Poland	Local Institution - 0085	Gdansk
Romania	Local Institution - 0034	Bucharest
Romania	Local Institution - 0031	Cluj Napoca
Romania	Local Institution - 0032	Craiova
Russian Federation	Local Institution - 0024	Moscow
Russian Federation	Local Institution - 0025	St.petersburg
Spain	Local Institution - 0054	A Coruña
Spain	Local Institution - 0053	Barcelona
Spain	Local Institution - 0052	Madrid
Spain	Local Institution - 0055	Malaga
Spain	Local Institution - 0056	Valencia
United Kingdom	Local Institution - 0050	Guildford
United Kingdom	Local Institution - 0049	London
United Kingdom	Local Institution - 0048	Tauton
United States	Local Institution - 0094	Charleston	South Carolina
United States	Memorial Health Systems	Colorado Springs	Colorado
United States	Local Institution - 0095	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Local Institution - 0058	Johnson City	New York
United States	Local Institution - 0006	Lancaster	Pennsylvania
United States	Local Institution - 0004	Lexington	Kentucky
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Local Institution - 0029	Marietta	Georgia
United States	Local Institution - 0098	Mineola	New York
United States	Local Institution - 0093	Pittsburgh	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Local Institution - 0044	Plainville	Connecticut
United States	Southwest Regional Cancer Clinic	Saint George	Utah
United States	Local Institution - 0091	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  France,  Germany,  Ireland,  Italy,  Japan,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	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.	From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
Secondary	Progression Free Survival (PFS) by BICR	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.	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)
Secondary	Objective Response Rate (ORR) by BICR	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.	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)
Secondary	Duration of Response (DoR)	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.	From date of first confirmed response to date of tumor progression (assessed up to October 2019, approximately 23 months)
Secondary	Time to Response (TTR)	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.	From date of randomization to date of first confirmed documented response (assessed up to October 2019, approximately 23 months)
Secondary	Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression	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%	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)
Secondary	PFS by BICR by PD-L1 Tumor Cell Expression	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.	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)
Secondary	OS by PD-L1 Tumor Cell Expression	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.	From date of randomization to date of death (assessed up to October 2019, approximately 23 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting