Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Voluntary written informed consent
Adult patients ≥ 18 years
Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in \>50% of tumor cells.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.
Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
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. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.

Criterios de exclusión

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

Ubicaciones

Instituto Médico Especializado Alexander Fleming

C.a.b.a., Buenos Aires, Argentina

Centro para la Atención Integral del Paciente Oncológico (CAIPO)

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto Oncológico de Córdoba (IONC)

Córdoba, Argentina

CORI - Centro Oncológico Riojano Integral

La Rioja, Argentina

ISIS Centro Especializado de Luce S.A.

Santa Fe, Argentina

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)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Lurbinectedin (PM01183)

Doxorubicin (DOX)

Cyclophosphamide (CTX)

Vincristine (VCR)

Topotecan