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Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

NCT06496048 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-12-12

No results posted yet for this study

Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Conditions

  • Relapsed Small Cell Lung Cancer

Interventions

DRUG

Lurbinectedin

Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)

DRUG

Irinotecan

Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk

DRUG

Lurbinectedin

Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)

DRUG

Topotecan

Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Ying Chen, Doctor · Jilin Provincial Tumor Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-14
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06496048 on ClinicalTrials.gov