An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

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

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

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 locally-advanced SCLC after first-line therapy. This study will enroll patients with thoracic disease but no distant metastases after first line treatment failure. 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

Start date
Jul 31, 2024
Status verified
Jul 2024
Primary completion
Mar 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Experimental Treatment: Lurbinectedin combined with Thoracic Radiotherapy
    Patients receive 2 cycles of lurbinectedin 2.6 mg/m2 combined with thoracic radiotherapy followed by 2 cycles of lurbinectedin 2.6 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 ]

Central Contacts

Related Studies