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

NCT05228496 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-09-26

No results posted yet for this study

Summary

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

Conditions

  • Lung Cancer, Small Cell

Interventions

DRUG

Tislelizumab

Tislelizumab 200mg IV D1, Q3W

DRUG

Sitravatinib

The starting dose of sitravatinib in this study is 70 mg, oral once daily. After receiving 1 cycle of starting dose at 70 mg once daily with sitravatinib, if patients were tolerated well with study treatment (without AEs definitely related to sitravatinib nor TRAEs leading to sitravatinib dose reduction and interruption), it is recommended to escalate sitravatinib dose to 100 mg once daily at the discretion of the investigators after discussion with patients.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2023-07-21
Completion
2025-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228496 on ClinicalTrials.gov