Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)

Sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Study ID
NCT04727853
Phase
PHASE2
Status
Completed

Conditions

  • Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity.

Key Dates

Start date
Mar 1, 2021
Status verified
Jun 2024
Primary completion
Apr 26, 2022
Completion
Apr 26, 2022

Study Design

Enrollment
66 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan liposome injection
    Patients will receive irinotecan liposome injection at 70 mg/m\^2 intravenously, over 90 min on Days 1 of every 14-day cycle.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From date of first dose until the date of first documented progression, assessed up to 24 months ]

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