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.
Age ≥ 19 years.
Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
Patients who failed treatment within 6 months after curative-intent chemotherapy are considered as having failed first-line therapy.
For platinum-sensitive patients, participation in the third-line cohort is allowed after re-treatment with a platinum-based regimen as second-line therapy (limited-stage).
Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).
Patients previously treated with Lurbinectedin or Paclitaxel.
Patients with limited-stage small cell lung cancer (LS-SCLC).
Patients with symptomatic or clinically significant brain metastases (patients with asymptomatic or stable brain metastases may be eligible; any treatment for brain metastases must have been completed at least 1 week prior to the first dose of study drug).
Parallel
Lurbinectedin
DrugAdministered IV at 2.2 mg/m² on Day 1 every 21-day cycle until disease progression or unacceptable toxicity.
Paclitaxel
DrugAdministered IV at 80 mg/m² on Days 1 and 8 every 21-day cycle until disease progression or unacceptable toxicity.
Objective Response Rate (ORR)
ORR is defined as the percentage of test subjects whose confirmed response was (RECIST 1.1) at least one full response (Complete Response, CR) or partial response (Partial Response, PR) before evidence of disease progression appears. The objective response rate is summarized for groups that can be evaluated for validity. The objective response rate is presented with a 95% confidence interval on both sides (assuming a normal distribution).
Progression-Free Survival (PFS) according to RECIST v1.1
PFS is defined as the period from the date of administration of the first clinical trial drug to the progression of the disease or death for any reason. The progression-free survival period is analyzed for groups that can be evaluated for validity.
PFS2 for the Two Regimens (Progression-Free Survival 2)
Progression-Free Survival (PFS) is defined as the time from the first administration date of the investigational drug in the clinical trial to the date of the second disease progression (PD) during subsequent chemotherapy, death, or death from any cause, whichever occurs first. PFS will be analyzed using the Kaplan-Meier method. The secondary progression-free survival will be analyzed in the efficacy evaluable population. If progression status cannot be assessed due to death during follow-up, end of survival confirmation, withdrawal of consent, or other reasons, the last disease assessment date will be censored.
Overall survival (OS)
Overall Survival (OS) is assessed based on the date of first administration of the investigational drug and the survival status at the time of analysis. OS is defined as the time from the first administration of the investigational drug to death from any cause. OS will be analyzed in the safety analysis set and presented using Kaplan-Meier plots. The number of events, median survival time (calculated from Kaplan-Meier curves), and the proportion of subjects without events will be summarized at 6, 12, and 18 months. The numbers and proportions of subjects who have died, are alive, lost to follow-up, or withdrawn consent will also be appropriately summarized.
Disease control rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of subjects whose best overall response (BOR), including both intracranial and extracranial responses, is complete response (CR), partial response (PR), responding, or stable disease (SD). DCR will be summarized in the efficacy evaluable population. DCR will be presented along with two-sided 95% confidence intervals, assuming a normal distribution
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