LAGOON

Primary Objective:

– To determine whether there is a difference in terms of overall survival (OS) between lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) (Group C) in patients with relapsed SCLC after failure of of one prior platinum containing chemotherapy line.

Secondary Objective:

– To determine whether there is a difference between lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) (Group C) in patients with relapsed SCLC after failure of one prior platinum-containing chemotherapy line in terms of:
o Progression-free survival (PFS)
o Overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
o Duration of response (DoR).

– To explore the antitumor activity (PFS, ORR and DoR) according to sensitive (chemotherapy–free interval [CTFI]≥90 days) and resistant (CTFI<90 days) disease.
– To evaluate the safety profile in each study arm.
– To evaluate patient-reported outcomes (PRO).
– To explore the efficacy and safety/tolerability between each lurbinectedin arm versus each control arm subset (topotecan or irinotecan).
– To explore the efficacy and safety/tolerability between lurbinectedin arms in case that both arms are significantly better than the control arm in the primary endpoint.
– To evaluate pharmacokinetics (PK) in patients treated with lurbinectedin and/or irinotecan in the experimental and control arms.
– To evaluate PK/pharmacodynamic (PD) correlations in patients treated with lurbinectedin and/or irinotecan in the experimental arms and control arms, if any.
– To evaluate pharmacogenomics (PGx) analyses. The purpose of this study is to collect information on whether lurbinectedin administered alone or lurbinectedin in combination with irinotecan (two different experimental arms; Groups A and B) is superior to a control group (Group C) consisting of topotecan or irinotecan in controlling small cell lung cancer (SCLC) evolution in patients who had progressed after receiving one chemotherapy-containing line of treatment which included platinum salts. Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator’s Choice (topotecan or irinotecan) as control arm (Group C), in SCLC patients who failed one prior platinum-containing line.