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Surufatinib in Combination of Durvalumab and EP/EC in the Firstly-line Treatment of ES-SCLC | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Surufatinib in Combination of Durvalumab and EP/EC in the Firstly-line Treatment of ES-SCLC

Multi-centered, Single-arm, Phase II Study on Surufatinib in Combination of Durvalumab and Etoposide and Carboplatin/Cisplatin in the Firstly-line Treatment of Extensive-stage Small-cell Lung Cancer

NCT05668767•Beijing Chest Hospital

View on ClinicalTrials.gov

Summary

Though great progress has been made in the treatment of SCLC in recent years, only two PD-L1 therapies are currently approved, treatment options are limited, and patient survival remains to be further improved. The current study aims to investigate the efficacy and safety of surufatinib combined with durvalumab combined with EP/EC regimen in first-line treatment of patients with extensive-stage SCLC, and to further explore the predictive biomarkers of this treatment combination.

Detailed Description

BACKGROUND: Small-cell lung cancer (SCLC) is an aggressive neuroendocrine tumor derived from bronchial epithelial cells, accounting for about 13-15% of all lung cancers. It has a rapid doubling time and high growth fraction, and tends to metastasize widely early in the course of the disease, resulting in 95% mortality. It is the most lethal subtype of lung cancer. Platinum-based chemotherapy is the first-line standard treatment for localized and extensive SCLC, with platinum combined with etoposide as the preferred regimen. However, chemotherapy options are limited and there remains a great unmet need for efficacy. In recent years, with the development of immunotherapy, chemotherapy combined with immunization has also become the treatment option for treatment-naïve patients, and PD-L1 inhibitor combined with chemotherapy first-line treatment has become a guideline class 1A recommendation; there is a significant benefit in OS compared with chemotherapy: in the IMpower 133 study, atezolizumab combined with EP regimen resulted in an OS of 12.3 months; in the CASPIAN study, Durvalumab combined with EP/EC regimen resulted in an OS of 13 months. An increasing number of targeted therapeutics have also been newly explored in the field of SCLC. In first-line treatment, PFS reached 9.6 months, OS reached 13.87 months, and ORR reached 77.8% with anlotinib in combination with EP/EC regimen. Though great progress has been made in the treatment of SCLC in recent years, only two PD-L1 therapies are currently approved, treatment options are limited, and patient survival remains to be further improved. The current study aims to investigate the efficacy and safety of surufatinib combined with durvalumab combined with EP/EC regimen in first-line treatment of patients with extensive-stage SCLC, and to further explore the predictive biomarkers of this treatment combination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. age ≥ 18 years;
•2. pathohistologically or cytologically confirmed small cell lung cancer with measurable lesions (RECIST 1.1, see Appendix 2);
•3. no previous systemic anti-tumor therapy;
•4. ECOG 0 or 1 (see Appendix 1);
•5. expected survival ≥ 12 weeks;
•6. at least one measurable lesion (RECIST 1.1 criteria);
•7. basically normal major organ and bone marrow function: a) blood routine: white blood cells ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L; b) international normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; c) liver function: total bilirubin ≤ 1.5 x ULN; in the absence of liver metastasis, ALT/AST/ALP ≤ 2.5 x ULN; in the presence of liver metastases,ALT/AST/ALP ≤ 5 x ULN; d) renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance (CCr) 60 mL/min (see Appendix 6); e) normal cardiac function, left ventricular ejection fraction (LVEF) ≥ 50% by two-dimensional echocardiography.
•8. fully understand the study, voluntarily participate, and sign the informed consent form.
•9. male or female patients of childbearing potential voluntarily use effective contraceptive methods during the study and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.All female patients will be considered to be of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (eg, hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).
•6. Other types of malignancy within 5 years or present;
+16 more criteria

Exclusion Criteria

•1. previously received systemic anti-tumor therapy for small cell lung cancer;
•2. tumors showing significant cavities or necrosis on imaging (CT or MRI)
•3. patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination suggesting brain or leptomeningeal lesions) (patients with brain metastases within 28 days before the completion of randomized treatment and symptoms from stable enrollment, but brain MRI examination is required, and CT or intravenous angiography confirms no symptoms of cerebral hemorrhage);
•4. patients who are participating in other clinical studies within 4 weeks after the end of previous clinical studies (except non-interventional studies);

Key Dates

Start Date

December 1, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2025

Last Updated

December 30, 2022

Enrollment

ESTIMATED participants

Conditions

Extensive-stage Small-cell Lung Cancer

Interventions

Surufatinib Durvalizumab EP/EC

DRUG

Contacts

Ying Hu

CONTACT

010-89509000 huying@bjxkyy.cn

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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: December 30, 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 in Combination of Durvalumab and EP/EC in the Firstly-line Treatment of ES-SCLC

Inclusion Criteria

Exclusion Criteria

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