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Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer

Efficacy and Safety of Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study

NCT05595889•Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

To evaluate the clinical efficacy and safety of surufatinib combined with irinotecan in the second line treatment of small cell lung cancer.

Detailed Description

According to the inclusion and exclusion criteria, 40 patients with small cell lung cancer who failed to receive standard first-line therapy were selected to evaluate the efficacy and safety of surufatinib combined with irinotecan in the second-line treatment of small cell lung cancer.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years; Volunteer to participate in the trial and sign informed consent;
•Small cell lung cancer diagnosed by histopathology;
•Previous failure to receive first-line standard treatment was defined as intolerable toxic and side effects, disease progression during treatment, or recurrence after treatment; Intolerability was defined as grade IV (thrombocytopenia grade III and above) for hematologic toxicity and grade III or above for nonhematologic toxicity. Note: Each line of drug refers to medication for at least 1 cycle regardless of single drug or multi-drug combination;
•ECOG score: 0-1;
•At least one lesion detectable by CT, according to RECIST 1.1;
•Expected survival ≥12 weeks;
•At least one measurable lesion (RECIST 1.1 criteria, see Appendix 2);
•The functions of major organs and bone marrow are basically normal:
•Blood routine: white blood cell ≥ 4.0 x 109/L, neutrophil ≥ 1.5 x 109/L, platelet ≥ 100 x 109/L, hemoglobin ≥ 90 g/L; A) International normalized ratio (INR) ≤1.5× upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5×ULN; B) Liver function: total bilirubin ≤ 1.5 x ULN; In the absence of liver metastasis, ALT/AST /ALP ≤ 2.5 x ULN; ALT/AST /ALP ≤ 5 x ULN in patients with liver metastasis; C) Renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance (CCr) 60 mL/min (see Appendix 6); D) Normal cardiac function, left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.
•Brain metastases must have been asymptomatic or treated and stabilized after discontinuation of steroids and anticonvulsants for at least 1 month prior to study treatment;
+2 more criteria

Exclusion Criteria

•Small cell lung cancer with other pathological types of tumors;
•Previously received anti-angiogenic drugs, including bevacizumab, sovanitinib, sunitinib, sorafenib, anlotinib, apatinib, etc.
•Receive the following treatments within the first 4 weeks of treatment, including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs;
•Pregnant or lactating women;
•With pleural effusion or ascites, respiratory syndrome (≥CTC AE grade 2 dyspnea);
•Symptomatic brain or meningeal metastases (except those who have undergone local radiotherapy or surgery for brain metastases for more than 6 months and have stable disease control);
•Severe infection (e.g., intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks prior to treatment, or unexplained fever \> 38.5 ° C during screening/initial administration;
•Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
•The urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantity \>1.0g;
•Obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding \> 30 mL within 3 months, hematemesis, melanism, blood in stool), hemoptysis (fresh blood \> 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event in the previous 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required;
+9 more criteria

Key Dates

Start Date

December 1, 2022

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2025

Last Updated

November 29, 2022

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung CancerAngiogenesisChemotherapy Effect

Interventions

Surufatinib

DRUG

Irinotecan

DRUG

Contacts

Zhiyong He

CONTACT

13805086391 heyong1015@163.com

Meifang Li

CONTACT

15985795022 362952772@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Surufatinib Combined With Irinotecan as a Second-line Treatment for Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

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