Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer

Sponsor
Yonsei University
Study ID
NCT07640932
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Carcinoma, Small Cell Lung

Eligibility Criteria

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

Interventions

  • Lurbinectedin — DRUG
    Administered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.
  • Paclitaxel — DRUG
    Administered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.

Study Details

This clinical trial is designed to compare and evaluate the efficacy and safety of the combination therapy of Lurbinectedin plus Paclitaxel (Combination Arm) versus Paclitaxel monotherapy (Monotherapy Arm) in patients with extensive-stage small-cell lung cancer whose disease has progressed after first-line chemotherapy.

Key Dates

Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Feb 28, 2029

Study Design

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

Arms

  • Experimental: Combination therapy of Lurbinectedin and Paclitaxel
    The study drugs are administered every 3 weeks until disease progression or unacceptable drug-related toxicity. Lurbinectedin is given IV at 2.2 mg/m² on Day 1, Paclitaxel IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF on Day 2, about 24 hours after chemotherapy.
  • Active Comparator: Paclitaxel monotherapy
    The study drugs are given every 3 weeks until disease progression or unacceptable drug-related toxicity. Paclitaxel is administered IV at 80 mg/m² on Days 1 and 8, and Pegylated G-CSF is given at the investigator's discretion.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: End of trial(approximately 3years) ]

Central Contacts

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