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

NCT05509699 | Completed Phase 2

• 1 other identifier: 2022-012-00CH1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  About 18 months

• Objective response rate

  About 18 months

• Disease control rate

  About 18 months

• Duration of response

  About 18 months

Study Arms (2)

Surufatinib in combination with anti-PD-1/L1 therapy

EXPERIMENTAL

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; Drug: Anti-PD-1/L1

Anti-PD-1/L1 monotherapy

EXPERIMENTAL

Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy

Drug: Anti-PD-1/L1

Interventions

Surufatinib DRUG

The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.

Surufatinib in combination with anti-PD-1/L1 therapy

Anti-PD-1/L1 DRUG

Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.

Also known as: Immune checkpoint inhibitor

Anti-PD-1/L1 monotherapy; Surufatinib in combination with anti-PD-1/L1 therapy

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 who sufficiently understand this study and is willing to sign the ICF;
• Aged from 18 to 75 years (inclusive);
• Patients with histologically or cytologically confirmed ES-SCLC ;
• 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;
• Patients with measurable lesions as defined in the RECIST v1.1 ;
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1;
• Adequate organ function:
• 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.

You may not qualify if:

• Previous use of anti-vascular endothelial growth factor (VEGF) drugs/anti-vascular endothelial growth factor receptor (VEGFR) agents;
• 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;
• Presence of central nervous system (CNS) metastasis and/or cancerous meningitis (metastases to meninges);
• 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;
• Uncontrollable malignant hydrothorax, ascites or pericardial effusion;
• Patients with active autoimmune disorder or immunodeficiency or history of autoimmune disorder or immunodeficiency;
• Patients with evidence or history of obvious bleeding tendency within 2 months prior to the first dose;
• Clinically significant cardiovascular disorders;
• Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia;
• Patients who are unable to take oral medications, or with previous surgical history or severe gastrointestinal;
• Pregnant (with a positive pregnancy test) or lactating women within 5 years before screening.
• Patients with a history of malignant tumors excluding small cell lung cancer (SCLC) within 5 years before screening.

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

surufatinib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Yi Hu, Postdoctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of two parts, i.e., a single-arm Phase IIa study and a randomized (1:1), controlled Phase IIb study. Phase IIa: It is planned that 20 patients will be enrolled to receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy . Phase IIb: It is planned that 40 patients will be enrolled to receive the following treatments: Group A: Patients will receive treatment with Surufatinib plus anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy. Group B: Patients will receive treatment with anti-PD-1/L1, the same immune checkpoint inhibitor from patients' first-line therapy.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: September 27, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)