Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
- Registration Number
- NCT02481830
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 569
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Chemotherapy Amrubicin Amrubicin Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment) Arm A Nivolumab Nivolumab Nivolumab intravenous infusion as specified Arm B Chemotherapy Topotecan Topotecan Topotecan as specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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) 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.Objective Response Rate (ORR) 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) 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.
Trial Locations
- Locations (151)
Local Institution - 0024
🇺🇸New Haven, Connecticut, United States
Local Institution - 0173
🇺🇸Johnson City, New York, United States
Local Institution - 0093
🇧🇷Barretos, Sao Paulo, Brazil
Local Institution - 0199
🇨🇳Beijing, Beijing, China
Local Institution - 0031
🇦🇺Elizabeth Vale, South Australia, Australia
Local Institution - 0084
🇦🇹Wels, Austria
Local Institution - 0188
🇨🇳Beijing, Beijing, China
Local Institution - 0198
🇨🇳Guangzhou, China
Local Institution - 0071
🇩🇪Frankfurt am Main, Germany
Local Institution - 0060
🇩🇪Gera, Germany
Local Institution - 0066
🇨🇿Praha 4, Czechia
Local Institution - 0054
🇩🇪Oberhausen, Germany
Local Institution - 0013
🇧🇪Bruxelles, Belgium
Local Institution - 0010
🇧🇪Yvoir, Belgium
Local Institution - 0102
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0030
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0011
🇧🇪Leuven, Belgium
Local Institution - 0019
🇩🇪Gerlingen, Germany
Local Institution - 0001
🇺🇸Durham, North Carolina, United States
Local Institution - 0194
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0027
🇦🇺Murdoch, Australia
Local Institution - 0110
🇭🇺Budapest, Hungary
Local Institution - 0068
🇨🇿Olomouc, Czechia
Local Institution - 0116
🇫🇷Lille Cedex, France
Local Institution - 0021
🇩🇪Grosshansdorf, Germany
Local Institution - 0058
🇩🇪Halle (saale), Germany
Local Institution - 0023
🇩🇪Koeln, Germany
Local Institution - 0085
🇦🇹Graz, Austria
Local Institution - 0002
🇺🇸Bethlehem, Pennsylvania, United States
Local Institution - 0099
🇧🇷Sao Paulo, Brazil
Local Institution - 0118
🇫🇷Paris Cedex 14, France
Local Institution - 0139
🇮🇱Beer Sheva, Israel
Local Institution - 0080
🇮🇹Monza, Italy
Local Institution - 0192
🇨🇳Shanghai, China
Local Institution - 0055
🇩🇪Berlin, Germany
Local Institution - 0059
🇩🇪Hamburg, Germany
Local Institution - 0112
🇭🇺Budapest, Hungary
Local Institution - 0047
🇩🇪Essen, Germany
Local Institution - 0020
🇩🇪Heidelberg, Germany
Local Institution - 0064
🇩🇪Regensburg, Germany
Local Institution - 0132
🇫🇷Reims, France
Local Institution - 0166
🇮🇱Safed, Israel
Local Institution - 0117
🇫🇷Toulon Cedex, France
Local Institution - 0046
🇩🇪Immenstadt, Germany
Local Institution - 0061
🇩🇪Bamberg, Germany
Local Institution - 0041
🇵🇱Gdansk, Poland
Local Institution - 0159
🇯🇵Nagoya-shi, Aichi, Japan
Local Institution - 0145
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Local Institution - 0083
🇬🇧Maidstone, Kent, United Kingdom
Local Institution - 0018
🇺🇸Atlanta, Georgia, United States
Local Institution - 0090
🇺🇸Cleveland, Ohio, United States
Local Institution - 0053
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0063
🇬🇷Heraklion, Creta, Greece
Local Institution - 0097
🇬🇷Thessaloniki, Greece
Local Institution - 0095
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0190
🇨🇳Beijing, Beijing, China
Local Institution - 0200
🇨🇳Beijing, Beijing, China
Local Institution - 0197
🇨🇳Guanzhou, Guangdong, China
Local Institution - 0189
🇨🇳Zhengzhou, Henan, China
Local Institution - 0186
🇨🇳Xian, Shaanxi, China
Local Institution - 0181
🇨🇳Shanghai, Shanghai, China
Local Institution - 0185
🇨🇳Shanghai, Shanghai, China
Local Institution - 0202
🇨🇳Urumqi, Xinjiang, China
Local Institution - 0182
🇨🇳Hangzhou, China
Local Institution - 0106
🇩🇰Copenhagen, Denmark
Local Institution - 0098
🇩🇰Herlev, Denmark
Local Institution - 0100
🇩🇰Odense, Denmark
Local Institution - 0143
🇨🇳Taichung, Taiwan
Local Institution - 0086
🇦🇹Wien, Austria
Local Institution - 0124
🇬🇧Sutton, Surrey, United Kingdom
Local Institution - 0123
🇬🇧Southampton, United Kingdom
Local Institution - 0088
🇺🇸Lincoln, Nebraska, United States
Local Institution - 0057
🇺🇸Lancaster, Pennsylvania, United States
Local Institution - 0089
🇺🇸Nashville, Tennessee, United States
Local Institution - 0070
🇺🇸Kennewick, Washington, United States
Local Institution - 0012
🇧🇪Edegem, Belgium
Local Institution - 0094
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0025
🇨🇱Recoleta, Santiago De Chile, Chile
Local Institution - 0187
🇨🇳Changchun, Jilin, China
Local Institution - 0201
🇨🇳Beijing, China
Local Institution - 0183
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0067
🇨🇿Brno, Czechia
Local Institution - 0069
🇨🇿Brno, Czechia
Local Institution - 0134
🇫🇷Brest, France
Local Institution - 0131
🇫🇷Pringy Cedex, France
Local Institution - 0022
🇩🇪Muenchen, Germany
Local Institution - 0138
🇮🇱Kfar Saba, Israel
Local Institution - 0136
🇮🇱Ramat -Gan, Israel
Local Institution - 0062
🇬🇷Athens, Greece
Local Institution - 0081
🇮🇹Bologna, Italy
Local Institution - 0073
🇮🇹Livorno, Italy
Local Institution - 0108
🇮🇹Lucca, Italy
Local Institution - 0078
🇮🇹Milano, Italy
Local Institution - 0077
🇮🇹Meldola, Italy
Local Institution - 0107
🇮🇹Rimini, Italy
Local Institution - 0079
🇮🇹Roma, Italy
Local Institution - 0196
🇯🇵Kashiwa, Chiba, Japan
Local Institution - 0153
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 0168
🇯🇵Akashi-shi, Hyogo, Japan
Local Institution - 0163
🇯🇵Kobe, Hyogo, Japan
Local Institution - 0155
🇯🇵Matsuyama, Ehime, Japan
Local Institution - 0164
🇯🇵Natori-shi, Miyagi, Japan
Local Institution - 0161
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0151
🇯🇵Osaka-sayama, Osaka, Japan
Local Institution - 0175
🇯🇵Hirakata-shi, Osaka, Japan
Local Institution - 0165
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0162
🇯🇵Kitaadachi-gun, Saitama, Japan
Local Institution - 0170
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0176
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0174
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0152
🇯🇵Wakayama-Shi, Wakayama, Japan
Local Institution - 0072
🇳🇴Oslo, Norway
Local Institution - 0154
🇯🇵Tokyo, Japan
Local Institution - 0146
🇰🇷Cheongju-si, Korea, Republic of
Local Institution - 0148
🇰🇷Seoul, Korea, Republic of
Local Institution - 0044
🇵🇱Elblag, Poland
Local Institution - 0096
🇳🇴Bergen, Norway
Local Institution - 0032
🇵🇱Krakow, Poland
Local Institution - 0033
🇵🇱Lodz, Poland
Local Institution - 0042
🇵🇱Poznan, Poland
Local Institution - 0035
🇵🇱Warszawa, Poland
Local Institution - 0135
🇷🇴Bucharest, Romania
Local Institution - 0114
🇷🇴Craiova, Romania
Local Institution - 0113
🇷🇴Romania, Romania
Local Institution - 0149
🇷🇴Timisoara, Timis, Romania
Local Institution - 0119
🇷🇺St. Petersburg, Russian Federation
Local Institution - 0126
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0121
🇷🇺Ryazan, Russian Federation
Local Institution - 0003
🇪🇸Madrid, Spain
Local Institution - 0007
🇪🇸Valencia, Spain
Local Institution - 0104
🇨🇭Basel, Switzerland
Local Institution - 0004
🇪🇸Madrid, Spain
Local Institution - 0133
🇨🇭Lausanne, Switzerland
Local Institution - 0109
🇨🇭Winterthur, Switzerland
Local Institution - 0156
🇨🇭Zurich, Switzerland
Local Institution - 0065
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0160
🇯🇵Sakai, Osaka, Japan
Local Institution - 0009
🇺🇸Nashville, Tennessee, United States
Local Institution - 0056
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0157
🇬🇧London, Greater London, United Kingdom
Local Institution - 0082
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0006
🇪🇸Barcelona, Spain
Local Institution - 0147
🇰🇷Seoul, Korea, Republic of
Local Institution - 0169
🇯🇵Nagoya, Aichi, Japan
Local Institution - 0171
🇯🇵Habikino-shi, Osaka, Japan
Local Institution - 0122
🇷🇺Moscow, Russian Federation
Local Institution - 0005
🇪🇸Barcelona, Spain
Local Institution - 0008
🇪🇸Sevilla, Spain
Local Institution - 0103
🇦🇺Kurralta Park, South Australia, Australia
Local Institution - 0028
🇦🇺Perth, Western Australia, Australia
Local Institution - 0150
🇭🇺Budapest, Hungary