At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 346 target
Drug / intervention
Sugemalimab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 15
- ✓Age 18 years or older
- ✓Histologically or cytologically confirmed small cell lung cancer
- ✓ECOG performance status 0-1
- ✓Limited-stage SCLC, Stage I-III by AJCC 8th Edition
Key exclusion· 11
- ✕Mixed small cell lung cancer or non-small cell lung cancer
- ✕Extensive-stage small cell lung cancer
- ✕Malignant pleural or pericardial effusion
- ✕Prior systemic anti-tumor therapy for SCLC or immune checkpoint inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05623267Phase 3RecruitingUpdate OverdueUpdated 34mo ago · Completion was 6mo agoEnrollment Stalled
Long Recruiting
Update Overdue
A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy
In Brief
A Phase 3 clinical trial evaluating Sugemalimab and Placebo for Limited Stage Small Cell Lung Cancer. Currently recruiting, targeting 346 participants across 1 site.
Signals
Enrollment appears stalled
Detailed Summary
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLimited Stage Small Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 3Recruiting
20232024202520262027
First PostedNov 2022
Enrollment StartJul 2023
Primary CompletionDec 2025
TodayJul 2026
Study CompletionMar 2027
First PostedNov 21, 2022
Enrollment StartJul 1, 2023
Primary CompletionDec 31, 2025
Study CompletionMar 31, 2027
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 3.6 years ago
Interventions
Sugemalimabdrug
Recombinant anti-PD-L1 fully human monoclonal antibody
Placebodrug
Placebo of Sugemalimab