Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in the Treatment of Small Cell Lung Cancer

A Phase Ⅰb/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer

To evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: Surufatinib,Etoposide,Cisplatin,Toripalimab; Drug: Surufatinib,Etoposide,Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have the ability to understand and voluntarily sign informed consent;
2. Age: ≥18 years old;
3. Expected survival period ≥ 3 months;
4. Adavanced small cell lung cancer confirmed by histology ;
5. According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
6. ECOG PS: 0-1;
7. Laboratory test indicators must meet the following requirements: Hematology: white blood cells ≥4.0×10^9/L, neutrophils ≥2.0×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90g/L. Liver function: serum bilirubin is lower than 1.5 times the maximum normal value; for patients without liver metastasis: ALT and AST are lower than 2.5 times the maximum normal value; for patients with liver metastasis: ALT and AST are lower than 5 times the maximum normal value ; Measured or calculated creatinine clearance: According to the Cockcroft-Gault formula (using actual body weight), patients receiving cisplatin treatment>60mL/min, and patients receiving carboplatin treatment>45mL/min;
8. Good compliance and follow-up;
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>3.0g;

5.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 (Allows to take beta blockers or digoxin); 6.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; 7.Patients with bleeding tendency or coagulation disorders, (14 days before randomization must meet: INR is within the normal range without the use of anticoagulants); 8.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); 9.Those who have received live vaccination within 4 weeks before the start of treatment; 10.Those who had suffered from tumors other than small cell lung cancer within 5 years before being enrolled in this study. Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor; 11.Severe unhealed wounds, ulcers or fractures; 12.Patients who are pregnant or breastfeeding ; 13.Any unstable conditions may endanger the safety of patients and affect their compliance with research; 14.Researchers think it is inappropriate to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib Combined With Toripalimab and Chemotherapy	Drug: Surufatinib,Etoposide,Cisplatin,Toripalimab; In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 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＋Toripalimab 240mg,d1,q3w was taken orally until the disease progressed.
Experimental: Surufatinib Combined With Chemotherapy	Drug: Surufatinib,Etoposide,Cisplatin; In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 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 was taken orally until the disease progressed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progress Free Survival(PFS)	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate(ORR)	up to 24 months
Overall Survival(OS)	up to 24 months
Disease control rate(DCR)	up to 24 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Etoposide phosphate; Cisplatin
• Other Study ID Numbers: HMPL-012-SPRING-L103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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