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

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05882630
Collaborator
Hunan Cancer Hospital (Other), Wuhan TongJi Hospital (Other)
39
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Surufatinib Combined With Serplulimab and EC Chemotherapy

Drug: Surufatinib,Serplulimab,Etoposide,Carboplatin
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.

Outcome Measures

Primary Outcome Measures

  1. Progress Free Survival(PFS) [up to 24 months]

Secondary Outcome Measures

  1. Objective response rate(ORR) [up to 24 months]

  2. Overall Survival(OS) [up to 24 months]

  3. Disease control rate(DCR) [up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujian Cancer Hospital Fuzhou Fujian China 350000

Sponsors and Collaborators

  • Fujian Cancer Hospital
  • Hunan Cancer Hospital
  • Wuhan TongJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05882630
Other Study ID Numbers:
  • HMPL-012-SPRING-L110
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide

Study Results

No Results Posted as of May 31, 2023