Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) Versus Cyclopho... | Recruiting
Clinical Trial of Lurbinectedin (PM... | Recruiting
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
ATLANTIS

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Medical Conditions
  • Small-cell Lung Cancer
Primary Contact Details
Pharma Mar Clinical Oncology Department
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02566993
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
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 to determine a difference in progression-free survival (PFS) by an Independent Review Committee (IRC) between lurbinectedin (PM01183)/doxorubicin (DOX) and the control arm (CAV) or topotecan and to analyze the median overall survival (OS) and mid- and long-term overall survival (OS at 12, 18 and 24 months).
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Lurbinectedin (PM01183), Drug : Doxorubicin (DOX), Drug : Cyclophosphamide (CTX), Drug : Vincristine (VCR), Drug : Topotecan

Study Arm Groups : Test, Test, Control 1, Control 1, Control 1, Control 2

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression-free survival (PFS); Every six weeks up to progression disease (aprox. 5 months)
Secondary Outcome Measures
    Overall survival (OS); Every three months up to death or study termination (aprox. 10 months); Overall survival rate 12, 18 & 24 months; Every three months up to death or study termination (aprox. 24 months)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
600
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Voluntary written informed consent

    2. Adult patients ≥ 18 years

    3. 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.

    4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2.

    5. Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization

    6. At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity

    7. 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.

    8. 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.

    Exclusion Criteria:

    1. More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)

    2. Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)

    3. Prior treatment with PM01183, topotecan or anthracyclines.

    4. Limited-stage patients who are candidates for local or regional therapy

    5. Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.

    6. Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization

    7. 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.

    8. Pregnant or breast feeding women
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W1G 6AD
London
NW1 2PG
Bristol
BS2 8ED
Site Reference ID/Investigator# 125695
Birkenhead
CH63 4JY
Worcestershire Acute Hospitals NHS Trust
Worcester
WR5 1DO
Trial Contact(s)
Primary Trial Contact
Pharma Mar Clinical Oncology Department
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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 (ATLANTIS Trial)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PM1183-C-003-14
Sponsor(s)
PharmaMar
Key Dates

Recruitment Start Date

Jul 2016

Recruitment End Date

Jun 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

24 Sep 2015

Date updated in source

19 Apr 2018