Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.
Inclusion Criteria:
Exclusion Criteria:
More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
Prior treatment with PM01183, topotecan or anthracyclines.
Limited-stage patients who are candidates for local or regional therapy
Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization
Concomitant diseases/conditions:
Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
Pregnant or breast feeding women
Chandler, Arizona 85224, United States
Fullerton, California 92835, United States
Fort Lauderdale, Florida 33308, United States
Metairie, Louisiana 70006, United States
Lebanon, New Hampshire 03756, United States
C.a.b.a., Buenos Aires C1426ANZ, Argentina
San Miguel de Tucumán, Tucumán Province T4000GTB, Argentina
Vienna, 1090, Austria
Rio de Janeiro, Rio de Janeiro 20231-092, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Pôrto Alegre, Rio Grande do Sul 90.035-903, Brazil
Panagyurishte, 4500, Bulgaria
Sofia, 1330, Bulgaria
Sofia, 1784, Bulgaria
Newmarket, Ontario L3Y 2P9, Canada
Greenfield Park, Quebec J4V 2H1, Canada
Marseille, 13915, France
Freiburg im Breisgau, 79106, Germany
Minden, 32429, Germany
München, 81925, Germany
Heraklion, Crete 71110, Greece
Athens, 14564, Greece
Thessaloniki, 57010, Greece
Budapest, 1121, Hungary
Székesfehérvár, 8000, Hungary
Catania, 95123, Italy
Ain Wazein, El Chouf, Lebanon
Bialystok, 15-027, Poland
Gdynia, 81-519, Poland
Otwock, 05-400, Poland
Poznan, 60-569, Poland
Craiova, Dolj 200347, Romania
Baia Mare, Maramureş 430031, Romania
Cluj-Napoca, 400015, Romania
Cluj-Napoca, 400015, Romania
Cluj-Napoca, 400015, Romania