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Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Surufatinib,Serplulimab,Etoposide,Carboplatin
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have the ability to understand and voluntarily sign informed consent; Age: 18-75 years old; Expected survival period ≥ 3 months; Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung carcinoma excepted); No prior systemic therapy for ES-SCLC; According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter; ECOG PS: 0-1; Major organs are functioning well; The urine or serum pregnancy test results of premenopausal women were negative. Exclusion Criteria: Patients with symptomatic brain metastases; People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg); Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0g; 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; 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. Patients with bleeding tendency or coagulation disorders; 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); Patients who are pregnant or breastfeeding; Allergy to any of the drugs in the study; Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large vessels; Researchers think it is inappropriate to participate in this trial.

Sites / Locations

  • Fujian Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surufatinib Combined With Serplulimab and EC Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Progress Free Survival(PFS)

Secondary Outcome Measures

Objective response rate(ORR)
Overall Survival(OS)
Disease control rate(DCR)

Full Information

First Posted
May 20, 2023
Last Updated
May 20, 2023
Sponsor
Fujian Cancer Hospital
Collaborators
Hunan Cancer Hospital, Wuhan TongJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05882630
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
Collaborators
Hunan Cancer Hospital, Wuhan TongJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surufatinib Combined With Serplulimab and EC Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Surufatinib,Serplulimab,Etoposide,Carboplatin
Intervention 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.
Primary Outcome Measure Information:
Title
Progress Free Survival(PFS)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Time Frame
up to 24 months
Title
Overall Survival(OS)
Time Frame
up to 24 months
Title
Disease control rate(DCR)
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have the ability to understand and voluntarily sign informed consent; Age: 18-75 years old; Expected survival period ≥ 3 months; Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung carcinoma excepted); No prior systemic therapy for ES-SCLC; According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter; ECOG PS: 0-1; Major organs are functioning well; The urine or serum pregnancy test results of premenopausal women were negative. Exclusion Criteria: Patients with symptomatic brain metastases; People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg); Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0g; 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; 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. Patients with bleeding tendency or coagulation disorders; 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); Patients who are pregnant or breastfeeding; Allergy to any of the drugs in the study; Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large vessels; Researchers think it is inappropriate to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gen Lin, Ph.D
Phone
+86-13313786157
Email
fjzllg133@fjzlhospital.com
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gen Lin, Ph.D
Phone
+86-13313786157
Email
fjzllg133@fjzlhospital.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

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