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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
PharmaMar
Study ID
NCT02566993
Phase
PHASE3
Status
Completed

Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin (PM01183) — DRUG
  • Doxorubicin (DOX) — DRUG
  • Cyclophosphamide (CTX) — DRUG
  • Vincristine (VCR) — DRUG
  • Topotecan — DRUG

Study Details

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 Dates

Start date
Aug 30, 2016
Status verified
Aug 2021
Primary completion
Feb 24, 2020
Completion
Feb 24, 2020

Study Design

Enrollment
613 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Lurbinectedin (PM01183) / Doxorubicin
  • Active Comparator: Control Arm 1
    CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
  • Active Comparator: Control Arm 2
    Topotecan

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Every three months up to death or study termination, a period of approximately 3.5 years ]

Locations (29)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama35243-
Ironwood Physicians P.C. dba Ironwood Cancer & Research CentersChandlerArizona85224-
St Jude Hospital Yorba Linda dba St Joseph Heritage HealthcareFullertonCalifornia92835-
Loma Linda University Medica! CenterLoma LindaCalifornia92354-
Innovative Clinical Research Institute (ICRI)WhittierCalifornia90603-
Boca Raton Regional Hospital Lynn Cancer InstituteBoca RatonFlorida33486-
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer CenterFort LauderdaleFlorida33308-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Joliet Oncology-Hematology Associates, Ltd.JolietIllinois60435-
Healthcare Research Network III, LLCTinley ParkIllinois60487-
Carle Cancer CenterUrbanaIllinois61801-
Norton Cancer InstituteLouisvilleKentucky40202-
Montgomery Cancer CenterMount SterlingKentucky40353-
East Jefferson Hematology-Oncology Metairie Physicians Services, IncMetairieLouisiana70006-
Anne Arundel Medical Center Oncology and HematologyAnnapolisMaryland21401-
Massachusetts General HospitalBostonMassachusetts02114-
QUEST Research InstituteRoyal OakMichigan48073-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial HospitalLebanonNew Hampshire03756-
Summit Medical Group, P.A.Florham ParkNew Jersey07932-
FirstHealth Outpatient Cancer CenterPinehurstNorth Carolina28374-
Gabrail Cancer Center ResearchCantonOhio44718-
Oklahoma Cancer Specialists and Research Institute, LLCTulsaOklahoma74146-
Associates in Hematology and Oncology, P.C.UplandPennsylvania19013-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
Tyler Hematology-Oncology PATylerTexas75701-
Medical Oncology Associates PS (dba Summit Cancer Centers)SpokaneWashington99208-
MultiCare Institute for Research & InnovationTacomaWashington98405-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Alabama Oncology· Birmingham, ALIronwood Physicians P.C. dba Ironwood Cancer & Research Centers· Chandler, AZSt Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare· Fullerton, CALoma Linda University Medica! Center· Loma Linda, CAInnovative Clinical Research Institute (ICRI)· Whittier, CABoca Raton Regional Hospital Lynn Cancer Institute· Boca Raton, FL

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