Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

An Open-Label, Multi-Center Phase II Study of Surufatinib Plus Anti-PD-1/L1 as Maintenance Therapy in Patients With Extensive-Stage Small Cell Lung Cancer

This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC.

Study Overview

• Status: Completed
• Conditions: Extensive-Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Surufatinib; Drug: Anti-PD-1/L1

Detailed Description

This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized, controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after prior platinum-based chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy and safety. Approximately 40 patients are planned to be enrolled in the randomized and controlled Phase IIb study with 20 patients per group.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who sufficiently understand this study and is willing to sign the ICF;
2. Aged from 18 to 75 years (inclusive);
3. Patients with histologically or cytologically confirmed ES-SCLC ;
4. Patients who did not have PD (assessed as per the RECIST v1.1) after prior first-line platinum-based chemotherapy plus an anti-PD-1/L1;
5. Patients with measurable lesions as defined in the RECIST v1.1 ;
6. Life expectancy ≥ 12 weeks;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1;
8. Adequate organ function:
9. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Male or female patients of childbearing potential should be willing to use effective contraceptive methods during the study and within 90 days after last dose of the study drug.

Exclusion Criteria:

1. Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular endothelial growth factor receptor (VEGFR) agents;
2. Use of systematic anti-tumor therapies other than first-line platinum-based chemotherapy in combination with anti-PD-1/L1 within 4 weeks prior to the first dose;
3. Presence of central nervous system (CNS) metastasis and/or cancerous meningitis (metastases to meninges);
4. Toxicities associated with previous anti-tumor treatment that has not been resolved to CTCAE Grade ≤ 1, except for alopecia and CTCAE Grade ≤ 2 peripheral neurotoxicity;
5. Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
6. Patients with active autoimmune disorder or immunodeficiency or history of autoimmune disorder or immunodeficiency;
7. Patients with evidence or history of obvious bleeding tendency within 2 months prior to the first dose;
8. Clinically significant cardiovascular disorders;
9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia;
10. Patients who are unable to take oral medications, or with previous surgical history or severe gastrointestinal;
11. Pregnant (with a positive pregnancy test) or lactating women within 5 years before screening.
12. Patients with a history of malignant tumors excluding small cell lung cancer (SCLC) within 5 years before screening.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surufatinib in combination with anti-PD-1/L1 therapy; Surufatinib 250 mg orally once plus anti-PD-1/L1, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.	Drug: Surufatinib; The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.; Drug: Anti-PD-1/L1; Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.; Other Names: Immune checkpoint inhibitor
Experimental: Anti-PD-1/L1 monotherapy; Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy	Drug: Anti-PD-1/L1; Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.; Other Names: Immune checkpoint inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival(PFS) assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)	About 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival (OS)	About 18 months
Objective response rate	Objective response rate (ORR) assessed per RECIST v1.1	About 18 months
Disease control rate	Disease control rate (DCR) assessed per RECIST v1.1	About 18 months
Duration of response	Duration of response (DoR) assessed per RECIST v1.1	About 18 months

Collaborators and Investigators

• Sponsor: Hutchison Medipharma Limited
• Investigators: Principal Investigator: Yi Hu, Postdoctor, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Immune Checkpoint Inhibitors; surufatinib
• Other Study ID Numbers: 2022-012-00CH1

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