Clinical trial NCT05882630: Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer
Official title: Surufatinib Combined With Serplulimab Plus Carboplatin and Etoposide as First-line Treatment for Extensive-stage Small-cell Lung Cancer：a Multicenter, Open-label, Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Hunan Cancer Hospital
name: Wuhan TongJi Hospital
First posted: 2023-05-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Progress Free Survival(PFS)
timeFrame: up to 24 months
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: up to 24 months
measure: Overall Survival(OS)
timeFrame: up to 24 months
measure: Disease control rate(DCR)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References: