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.
PRIMARY OBJECTIVE: To describe the safety in terms of radiation therapy (RT) in combination with lurbinectedin in SCLC patients with Single-lesion progression after first course treatment. SECONDARY OBJECTIVES: To evaluate the preliminary efficacy of RT plus lurbinectedin, as assessed by Progression free survival (PFS) and Overall survival (OS). OUTLINE: Patients receive 2 cycles of lurbinectedin combined with radiotherapy followed by lurbinectedin alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle. G-CSF(Granulocyte Colony-Stimulating Factor) will be used for prophylaxis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
2.6 mg/m2 , Given IV, every 21 days
Thoracic radiotherapy
National Cancer Center/Cancer Hospital
Beijing, China
Incidence of adverse events of radio therapy with lurbinectedin
≥grade 4 treatment related adverse events within 30 days of final RT fraction; Any treatment related adverse events leading to dose delays or reductions of lurbinectedin; Any treatment related serious adverse events .
Time frame: 30 days following treatment completion
Progression free survival (PFS)
PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated.
Time frame: From protocol treatment initiation to disease progression or death, assessed up to 24 months
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated.
Time frame: From treatment initiation to death, , assessed up to 24 months
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