Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

Lung Cancer Clinical Trial

— CheckMate331  

Official title:

An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481830
• Other study ID #: CA209-331
• Secondary ID: 2015-001097-18
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2015
• Est. completion date: August 30, 2022

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: August 30, 2022
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
• Subjects with either limited or extensive disease stage at the initial diagnosis
• Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases
• Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
• Inadequate hematologic or hepatic function

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Nivolumab

• Topotecan

• Amrubicin

Locations

Country	Name	City	State
Australia	Local Institution - 0030	Brisbane	Queensland
Australia	Local Institution - 0031	Elizabeth Vale	South Australia
Australia	Local Institution - 0103	Kurralta Park	South Australia
Australia	Local Institution - 0027	Murdoch
Australia	Local Institution - 0028	Perth	Western Australia
Australia	Local Institution - 0102	Waratah	New South Wales
Austria	Local Institution - 0085	Graz
Austria	Local Institution - 0084	Wels
Austria	Local Institution - 0086	Wien
Belgium	Local Institution - 0013	Bruxelles
Belgium	Local Institution - 0012	Edegem
Belgium	Local Institution - 0011	Leuven
Belgium	Local Institution - 0010	Yvoir
Brazil	Local Institution - 0093	Barretos	Sao Paulo
Brazil	Local Institution - 0095	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0094	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 0099	Sao Paulo
Chile	Local Institution - 0025	Recoleta	Santiago De Chile
China	Local Institution - 0188	Beijing	Beijing
China	Local Institution - 0190	Beijing	Beijing
China	Local Institution - 0199	Beijing	Beijing
China	Local Institution - 0200	Beijing	Beijing
China	Local Institution - 0201	Beijing
China	Local Institution - 0187	Changchun	Jilin
China	Local Institution - 0198	Guangzhou
China	Local Institution - 0197	Guanzhou	Guangdong
China	Local Institution - 0182	Hangzhou
China	Local Institution - 0183	Hangzhou	Zhejiang
China	Local Institution - 0194	Nanjing	Jiangsu
China	Local Institution - 0181	Shanghai	Shanghai
China	Local Institution - 0185	Shanghai	Shanghai
China	Local Institution - 0192	Shanghai
China	Local Institution - 0202	Urumqi	Xinjiang
China	Local Institution - 0186	Xian	Shaanxi
China	Local Institution - 0189	Zhengzhou	Henan
Czechia	Local Institution - 0067	Brno
Czechia	Local Institution - 0069	Brno
Czechia	Local Institution - 0068	Olomouc
Czechia	Local Institution - 0066	Praha 4
Denmark	Local Institution - 0106	Copenhagen
Denmark	Local Institution - 0098	Herlev
Denmark	Local Institution - 0100	Odense
France	Local Institution - 0134	Brest
France	Local Institution - 0116	Lille Cedex
France	Local Institution - 0118	Paris Cedex 14
France	Local Institution - 0131	Pringy Cedex
France	Local Institution - 0132	Reims
France	Local Institution - 0117	Toulon Cedex
Germany	Local Institution - 0061	Bamberg
Germany	Local Institution - 0055	Berlin
Germany	Local Institution - 0047	Essen
Germany	Local Institution - 0071	Frankfurt am Main
Germany	Local Institution - 0060	Gera
Germany	Local Institution - 0019	Gerlingen
Germany	Local Institution - 0021	Grosshansdorf
Germany	Local Institution - 0058	Halle (saale)
Germany	Local Institution - 0059	Hamburg
Germany	Local Institution - 0020	Heidelberg
Germany	Local Institution - 0046	Immenstadt
Germany	Local Institution - 0023	Koeln
Germany	Local Institution - 0022	Muenchen
Germany	Local Institution - 0054	Oberhausen
Germany	Local Institution - 0064	Regensburg
Greece	Local Institution - 0062	Athens
Greece	Local Institution - 0063	Heraklion	Creta
Greece	Local Institution - 0097	Thessaloniki
Hungary	Local Institution - 0110	Budapest
Hungary	Local Institution - 0112	Budapest
Hungary	Local Institution - 0150	Budapest
Israel	Local Institution - 0139	Beer Sheva
Israel	Local Institution - 0138	Kfar Saba
Israel	Local Institution - 0136	Ramat -Gan
Israel	Local Institution - 0166	Safed
Italy	Local Institution - 0081	Bologna
Italy	Local Institution - 0073	Livorno
Italy	Local Institution - 0108	Lucca
Italy	Local Institution - 0077	Meldola
Italy	Local Institution - 0078	Milano
Italy	Local Institution - 0080	Monza
Italy	Local Institution - 0107	Rimini
Italy	Local Institution - 0079	Roma
Japan	Local Institution - 0168	Akashi-shi	Hyogo
Japan	Local Institution - 0176	Bunkyo-ku	Tokyo
Japan	Local Institution - 0170	Chuo-ku	Tokyo
Japan	Local Institution - 0174	Chuo-ku	Tokyo
Japan	Local Institution - 0153	Fukuoka-shi	Fukuoka
Japan	Local Institution - 0171	Habikino-shi	Osaka
Japan	Local Institution - 0175	Hirakata-shi	Osaka
Japan	Local Institution - 0196	Kashiwa	Chiba
Japan	Local Institution - 0162	Kitaadachi-gun	Saitama
Japan	Local Institution - 0163	Kobe	Hyogo
Japan	Local Institution - 0155	Matsuyama	Ehime
Japan	Local Institution - 0169	Nagoya	Aichi
Japan	Local Institution - 0159	Nagoya-shi	Aichi
Japan	Local Institution - 0164	Natori-shi	Miyagi
Japan	Local Institution - 0161	Niigata-shi	Niigata
Japan	Local Institution - 0151	Osaka-sayama	Osaka
Japan	Local Institution - 0165	Osaka-shi	Osaka
Japan	Local Institution - 0160	Sakai	Osaka
Japan	Local Institution - 0154	Tokyo
Japan	Local Institution - 0152	Wakayama-Shi	Wakayama
Korea, Republic of	Local Institution - 0146	Cheongju-si
Korea, Republic of	Local Institution - 0147	Seoul
Korea, Republic of	Local Institution - 0148	Seoul
Korea, Republic of	Local Institution - 0145	Suwon	Gyeonggi-do
Norway	Local Institution - 0096	Bergen
Norway	Local Institution - 0072	Oslo
Poland	Local Institution - 0044	Elblag
Poland	Local Institution - 0041	Gdansk
Poland	Local Institution - 0032	Krakow
Poland	Local Institution - 0033	Lodz
Poland	Local Institution - 0042	Poznan
Poland	Local Institution - 0035	Warszawa
Romania	Local Institution - 0135	Bucharest
Romania	Local Institution - 0114	Craiova
Romania	Local Institution - 0113	Romania
Romania	Local Institution - 0149	Timisoara, Timis
Russian Federation	Local Institution - 0122	Moscow
Russian Federation	Local Institution - 0121	Ryazan
Russian Federation	Local Institution - 0126	Saint-Petersburg
Russian Federation	Local Institution - 0119	St. Petersburg
Spain	Local Institution - 0005	Barcelona
Spain	Local Institution - 0006	Barcelona
Spain	Local Institution - 0003	Madrid
Spain	Local Institution - 0004	Madrid
Spain	Local Institution - 0008	Sevilla
Spain	Local Institution - 0007	Valencia
Switzerland	Local Institution - 0104	Basel
Switzerland	Local Institution - 0133	Lausanne
Switzerland	Local Institution - 0109	Winterthur
Switzerland	Local Institution - 0156	Zurich
Taiwan	Local Institution - 0143	Taichung
United Kingdom	Local Institution - 0157	London	Greater London
United Kingdom	Local Institution - 0083	Maidstone	Kent
United Kingdom	Local Institution - 0082	Manchester	Greater Manchester
United Kingdom	Local Institution - 0123	Southampton
United Kingdom	Local Institution - 0124	Sutton	Surrey
United States	Local Institution - 0018	Atlanta	Georgia
United States	Local Institution - 0002	Bethlehem	Pennsylvania
United States	Local Institution - 0090	Cleveland	Ohio
United States	Local Institution - 0001	Durham	North Carolina
United States	Local Institution - 0173	Johnson City	New York
United States	Local Institution - 0070	Kennewick	Washington
United States	Local Institution - 0057	Lancaster	Pennsylvania
United States	Local Institution - 0088	Lincoln	Nebraska
United States	Local Institution - 0065	Little Rock	Arkansas
United States	Local Institution - 0009	Nashville	Tennessee
United States	Local Institution - 0089	Nashville	Tennessee
United States	Local Institution - 0024	New Haven	Connecticut
United States	Local Institution - 0053	Philadelphia	Pennsylvania
United States	Local Institution - 0056	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Chile,  China,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.	OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy.; Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.	From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression.; CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.; PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.	From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting