Malignant neoplasm of bronchus and lung
Conditions
Interventions
Drug
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
Sponsors
Hospital de Caridade de Ijui
INC Research
Pharma Mar S.A.
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: More than one prior chemotherapy-containing regimen (including patients re-challenged with same initial regimen); Patients who never received any platinum-containing regimen for SCLC treatment; Prior treatment with PM01183, topotecan or anthracyclines; Limited-stage patients who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization; Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization; Symptomatic, or steroid-requiring, or progressing CNS disease involvement during at least four weeks prior to randomization; Concomitant diseases/conditions: History (within one year prior to randomization) or presence of unstable angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease; Symptomatic or uncontrolled arrhythmia despite ongoing treatment; Patients with any immunodeficiency, including those known to be or have been infected by human immunodeficiency virus (HIV); Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin, Active infection or increased risk due to external drainages, Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease (ILD) or pulmonary fibrosis, Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, and who has been continuously in remission since then will be permitted, Limitation of the patient’s ability to comply with the treatment or to follow the protocol, Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization; Pregnant or breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Mexico, Netherlands, Poland, Portugal, Romania, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactCynthia Ventura
INC Research
Outcome results
None listed