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

NCT05882630 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HMPL-012-SPRING-L110
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival(PFS)

  up to 24 months

Secondary Outcomes (3)

• Objective response rate(ORR)

  up to 24 months

• Overall Survival(OS)

  up to 24 months

• Disease control rate(DCR)

  up to 24 months

Study Arms (1)

Surufatinib Combined With Serplulimab and EC Chemotherapy

EXPERIMENTAL

Drug: Surufatinib,Serplulimab,Etoposide,Carboplatin

Interventions

Surufatinib,Serplulimab,Etoposide,Carboplatin DRUG

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.

Surufatinib Combined With Serplulimab and EC Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Hunan Cancer Hospital: collaborator
• Wuhan TongJi Hospital: collaborator

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Gen Lin, Ph.D

CONTACT

+86-13313786157; fjzllg133@fjzlhospital.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)