Actively Recruiting
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT
Led by Sun Yat-sen University · Updated on 2023-08-07
346
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Histologically or cytologically confirmed small cell lung cancer
- ECOG performance status of 0 or 1 at enrollment
- Limited-stage SCLC (Stage I-III) suitable for definitive radiation
- Inoperable SCLC, contraindication to surgery, or refusal of surgery
- Completed 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy
- Prophylactic intracranial irradiation allowed after chemoradiotherapy
- Concurrent radiotherapy started no later than last day of second chemotherapy cycle; max 35 days between chemotherapy end and radiotherapy start for sequential therapy
- Radiotherapy dose: 60-66 Gy over 6 weeks (standard) or 45 Gy over 3 weeks (hyperfractionated)
- No progression after chemoradiotherapy (complete response, partial response, or stable disease)
- First dose of sugemalimab within 42 days after chemoradiation; within 56 days if prophylactic intracranial irradiation given
- Life expectancy of at least 12 weeks
- Ability to provide tumor tissue samples for whole exome sequencing
- Women of childbearing potential and fertile men must use effective contraception from consent until 180 days after last dose
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Good compliance and voluntary informed consent
You will not qualify if you...
- Mixed small cell lung cancer or non-small cell lung cancer diagnosis
- Extensive-stage small cell lung cancer
- Malignant pleural or pericardial effusion
- Prior systemic anti-tumor therapy for SCLC or immune checkpoint inhibitors
- Active, unstable systemic diseases including infections, uncontrolled hypertension, heart failure NYHA class II or higher, unstable angina, acute coronary syndrome, severe arrhythmia, or severe liver, kidney, or metabolic diseases
- History or active interstitial lung disease requiring systemic glucocorticoids or immunosuppressive therapy
- Other malignancies within 5 years except certain skin or carcinoma in situ
- Pregnant or breastfeeding women
- Allergy to study drug or components
- Inability to comply with study requirements or complete study
- Insufficient bone marrow or other important organ function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Shen Zhao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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