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Trial Title:
Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer
NCT ID:
NCT05882630
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib,Serplulimab,Etoposide,Carboplatin
Description:
In dose escalation, Surufatinib will be administered orally (PO) once daily (QD)
,d1-21,q3w + Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w + Carboplatin
AUC=5,d1,q3w; 4-6 cycles in total.
At the indication-specific expansion portion of the study, patients will receive
surufatinib RP2D,d1-21,q3w+Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w
+ Carboplatin AUC=5,d1,q3w, 4-6 cycles in total. After the end of the first-line
treatment, patients with CR, PR, and SD can continue to maintenance treatment with
Surufatinib RP2D,d1-21,q3w＋Serplulimab 4.5 mg/kg ivgtt,d1,q3w until the disease
progressed.
Arm group label:
Surufatinib Combined With Serplulimab and EC Chemotherapy
Summary:
To evaluates the effectiveness and safety of Surufatinib combined with Serplulimab plus
chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are
Surufatinib combined with Serplulimab
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must have the ability to understand and voluntarily sign informed consent;
2. Age: 18-75 years old;
3. Expected survival period ≥ 3 months;
4. Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung
carcinoma excepted);
5. No prior systemic therapy for ES-SCLC;
6. According to the RECIST 1.1 standard, the patient has at least one target lesion
with a measurable diameter;
7. ECOG PS: 0-1;
8. Major organs are functioning well;
9. The urine or serum pregnancy test results of premenopausal women were negative.
Exclusion Criteria:
1. Patients with symptomatic brain metastases;
2. People with hypertension who cannot be well controlled by double antihypertensive
drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
3. Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein
quantification>1.0g;
4. Cardiovascular disease history: congestive heart failure> New York Heart Association
(NYHA) standard II, patients with active coronary artery disease (those with
myocardial infarction 6 months before enrollment can be enrolled), arrhythmia
requiring treatment;
5. Active severe clinical infections (>NCI-CTCAE 5.0 version 2 infection criteria),
including tuberculosis (clinical evaluation, including clinical history, physical
examination, imaging findings and TB examination in line with local clinical
practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or
human immunodeficiency virus (HIV 1/2 antibody positive);Patients who have
previously had HBV infection or have been cured (defined as the presence of
hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C
virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase
chain reaction is negative.
6. Patients with bleeding tendency or coagulation disorders;
7. In the past 2 years, there are active autoimmune diseases that require systemic
treatment (such as corticosteroids or immunosuppressive drugs), and related
alternative treatments (such as thyroxine, insulin, or physiological corticosteroid
replacement for renal or pituitary insufficiency) are allowed treatment);
8. Patients who are pregnant or breastfeeding;
9. Allergy to any of the drugs in the study;
10. Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large
vessels;
11. Researchers think it is inappropriate to participate in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350000
Country:
China
Contact:
Last name:
Gen Lin, Ph.D
Phone:
+86-13313786157
Email:
fjzllg133@fjzlhospital.com
Start date:
June 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan TongJi Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882630
