Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Completed · Phase 3

Conditions studied: Small-cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02566993

Run by

PharmaMar

People needed

613

Starts

2016-08-30

Expected to finish

2020-02-24

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers — Chandler, Arizona, United States
• St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare — Fullerton, California, United States
• Loma Linda University Medica! Center — Loma Linda, California, United States
• Innovative Clinical Research Institute (ICRI) — Whittier, California, United States
• Boca Raton Regional Hospital Lynn Cancer Institute — Boca Raton, Florida, United States
• Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center — Fort Lauderdale, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Healthcare Research Network III, LLC — Tinley Park, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Montgomery Cancer Center — Mount Sterling, Kentucky, United States
• East Jefferson Hematology-Oncology Metairie Physicians Services, Inc — Metairie, Louisiana, United States
• Anne Arundel Medical Center Oncology and Hematology — Annapolis, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• QUEST Research Institute — Royal Oak, Michigan, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital — Lebanon, New Hampshire, United States
• Summit Medical Group, P.A. — Florham Park, New Jersey, United States
• FirstHealth Outpatient Cancer Center — Pinehurst, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma, United States
• Associates in Hematology and Oncology, P.C. — Upland, Pennsylvania, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• Alabama Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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