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

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT06496048
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Relapsed Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Lurbinectedin — DRUG
    Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
  • Irinotecan — DRUG
    Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
  • Lurbinectedin — DRUG
    Lurbinectedin 2.0 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)
  • Topotecan — DRUG
    Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk

Study Details

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.

Key Dates

Start date
Sep 14, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lurbinectedin monotherapy
  • Experimental: Lurbinectedin + Irinotecan combined therapy
  • Active Comparator: Topotecan

Primary Outcome Measure

Overall survival (OS) [ Time Frame: from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject ]

Central Contacts

Related Studies