Clinical Trial of Lurbinectedin / Doxorubicin versus Cyclophosphamide, Doxorubicin and Vincristine or Topotecan as Treatment in Patients with Lung Cancer.

INTERVENTION: Arm 1: lurbinectedin (PM01183)/ Doxorubicin, intravously, on 165 patients, up to a maximum of 10 cycles Arm 2: cyclophosphamide, doxorubicin and vicristin or topotecan, up to a maximum of 10 cycles E02.319.310 N04.452.706.477 CONDITION: C00‐D48 Malignant neoplasm of bronchus and lung ; C34 PRIMARY OUTCOME: Measure the Progression‐free survival (PFS) by an Independent Review Committee (IRC), based on the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). SECONDARY OUTCOME: To analyze: ; Overall survival (OS); Mid‐ and long‐term survival (OS at 12, 18 and 24 months, respectively); Efficacy and safety profiles in the subgroups of the PM01183/DOX arm vs. CAV or topotecan; PFS by Investigator’s Assessment (IA); Antitumor activity according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1; Safety profile; Patient‐reported outcomes (PRO); Pharmacokinetics (PK) of the combination in patients treated in the experimental arm (PM01183/DOX); PK/pharmacodynamic (PDy) correlations in the experimental arm, if any; Pharmacogenetics of known polymorphisms in patients treated in the experimental arm. ; INCLUSION CRITERIA: Voluntary written informed consent of the patient; Adult patients aged more than 18 years; Diagnosis of limited or extensive stage small cells lung cancer (SCLC); Small‐cell carcinoma of unknown primary site with or without neuroendocrine; ECOG PS lower than 2; Adequate hematological, renal, metabolic and hepatic function in an assessment performed within 7 days (+ 3 day window) of randomization; At least three weeks since last prior anticancer treatment and recovery to grade less than 1 from any AE related to previous anticancer treatment; Prior Radiotheraphy (RT): At least four weeks since completion of whole‐brain RT (WBRT), at least two weeks since completion of PCI, and to any other site not previously specified; Evidence of non‐childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation.