An Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06501976
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Lurbinectedin — DRUG
    2.6 mg/m2 , Given IV, every 21 days
  • Radiation Therapy — RADIATION
    Thoracic radiotherapy

Study Details

This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat SCLC with Single-lesion progression after first course treatment. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.

Key Dates

First listed
Jul 15, 2024
Start date
Dec 31, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Treatment: Lurbinectedin combined with Radiotherapy
    Patients receive 2 cycles of lurbinectedin 3.2 mg/m2 combined with radiotherapy followed by lurbinectedin 3.2 mg/m2 alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle.

Primary Outcome Measure

Incidence of adverse events of radio therapy with lurbinectedin [ Time Frame: 30 days following treatment completion ]

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