A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy for ES-SCLC

NCT05896059 | Unknown Phase 2

• 1 other identifier: [2022]-12-23
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year PFS rate assessed by investigator in maintenance phase-patient analysis set per RECIST v1.1.

  PFS is defined as the time from the first dose of study drug(s) in maintenance phase to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first.

  Start of maintenance therapy until 1-year follow-up

Secondary Outcomes (6)

• PFS

  up to 2 year

• OS

  up to 2 year

• ORR

  up to 2 year

• DCR

  up to 2 year

• DOR

  up to 2 year

Study Arms (1)

Tislelizumab combined with Anlotinib

EXPERIMENTAL

Drug: Tislelizumab; Drug: Anlotinib

Interventions

Tislelizumab DRUG

Tislelizumab，200mg，D1, intravenous，Q3W；

Tislelizumab combined with Anlotinib

Anlotinib DRUG

Anlotinib，12mg，oral administration，QD.

Tislelizumab combined with Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed ES-SCLC, defined by the American Joint Committee on Cancer (AJCC) 8th edition or the Veterans Administration Lung Study Group (VALG) staging system.
• No prior treatment for ES-SCLC. (Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of ≥ 6 months between the completion of chemotherapy, radiotherapy, or chemoradiotherapy and diagnosis of ES-SCLC).
• ECOG performance status ≤ 1.
• Life expectancy ≥ 3 months.
• Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose):
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L，hemoglobin ≥ 90 g/L.
• International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
• Serum total bilirubin ≤ 1.5 x ULN.
• Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN for patients with liver metastases.
• Serum albumin (ALB) ≥ 25g/L.
• Serum creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.
• to 75 years old on the day of signing the informed consent form (ICF).
• Fertile patients must be willing to use highly effective contraception during the study period and for 120 days after the last dose of tislelizumab.

You may not qualify if:

• Active leptomeningeal disease or uncontrolled, untreated brain metastasis:
• Patients with a history of treated and, at the time of screening, asymptomatic central nervous system (CNS) metastases are eligible if they meet all the following:
• only supratentorial metastases allowed.
• No radiotherapy for the central nervous system within 14 days prior to screening.
• Untreated and Asymptomatic patients with brain metastasis brain metastases can be included in the study after judgment by the investigators, but regular brain imaging examinations of the disease site are required.
• Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
• Received prior anti-VEGF or VEGFR TKI agents including but not limited to Anlotinib.
• Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 28 days prior to initiation of study treatment.
• Clinically uncontrolled pleural effusion, ascites, pericardial effusion that requires treatment and may affect study treatment estimated by investigator.
• History of allergic reactions to any study drugs or any component of the preparation or any component of the container.
• Patients with untreated chronic hepatitis B (HBV) or chronic HBV carriers whose HBV DNA ≥ 500 IU/mL (2500 copies/mL), patients with active hepatitis C (HCV).
• Active autoimmune diseases that require treatment and may affect study treatment estimated by investigator.
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or any other immunosuppressive medication≤ 14 days before first dose of study drugs that may affect study treatment estimated by investigator.
• Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, within 14 days prior to first dose of study drug(s). Note: antiviral therapy is permitted for patients with viral hepatitis.
• Prior allogeneic stem cell transplantation or organ transplantation.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; anlotinib

Central Study Contacts

Yun Fan

CONTACT

+86-13858182310; fanyun@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 9, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

CN (1)