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).
Yonsei University
Lead sponsor