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Trial record 1 of 30 for:    atlantis lung
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Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (ATLANTIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566993
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE August 30, 2016
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
Overall survival (OS) [ Time Frame: Every three months up to death or study termination (aprox. 10 months) ]
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
Progression-free survival (PFS) [ Time Frame: Every six weeks up to progression disease (aprox. 5 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • Progression-free survival (PFS) [ Time Frame: Every six weeks up to progression disease (aprox. 5 months) ]
    Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy.
  • Best antitumor response [ Time Frame: Every three months up to death or study termination (aprox. 24 months) ]
    Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2015)
  • Overall survival (OS) [ Time Frame: Every three months up to death or study termination (aprox. 10 months) ]
  • Overall survival rate 12, 18 & 24 months [ Time Frame: Every three months up to death or study termination (aprox. 24 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer
Official Title  ICMJE 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)
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small-cell Lung Cancer
Intervention  ICMJE
  • Drug: Lurbinectedin (PM01183)
  • Drug: Doxorubicin (DOX)
  • Drug: Cyclophosphamide (CTX)
  • Drug: Vincristine (VCR)
  • Drug: Topotecan
Study Arms  ICMJE
  • Experimental: Experimental Arm
    Lurbinectedin (PM01183) / Doxorubicin
    Interventions:
    • Drug: Lurbinectedin (PM01183)
    • Drug: Doxorubicin (DOX)
  • Active Comparator: Control Arm 1
    CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
    Interventions:
    • Drug: Doxorubicin (DOX)
    • Drug: Cyclophosphamide (CTX)
    • Drug: Vincristine (VCR)
  • Active Comparator: Control Arm 2
    Topotecan
    Intervention: Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
613
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2015)
600
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Greece,   Hungary,   Italy,   Lebanon,   Netherlands,   Poland,   Portugal,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02566993
Other Study ID Numbers  ICMJE PM1183-C-003-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PharmaMar
Study Sponsor  ICMJE PharmaMar
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmaMar
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP