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 - 0065
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0024
🇺🇸New Haven, Connecticut, United States
Local Institution - 0018
🇺🇸Atlanta, Georgia, United States
Local Institution - 0056
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0088
🇺🇸Lincoln, Nebraska, United States
Local Institution - 0173
🇺🇸Johnson City, New York, United States
Local Institution - 0001
🇺🇸Durham, North Carolina, United States
Local Institution - 0090
🇺🇸Cleveland, Ohio, United States
Local Institution - 0002
🇺🇸Bethlehem, Pennsylvania, United States
Local Institution - 0057
🇺🇸Lancaster, Pennsylvania, United States
Scroll for more (141 remaining)Local Institution - 0065🇺🇸Little Rock, Arkansas, United States