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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

NCT02566993

Description:

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 whether there is a difference in Overall Survival (OS) between lurbinectedin (PM01183)/doxorubicin (DOX) and a control arm consisting of best investigator's choice between CAV or topotecan and to analyze progression-free survival (PFS) by an Independent Review Committee (IRC).

Related Conditions:
  • Small Cell Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: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
  • Official 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)

Clinical Trial IDs

  • ORG STUDY ID: PM1183-C-003-14
  • NCT ID: NCT02566993

Trial Conditions

  • Small-cell Lung Cancer

Trial Interventions

DrugSynonymsArms
Lurbinectedin (PM01183)Test
Doxorubicin (DOX)Test
Cyclophosphamide (CTX)Control 1
Vincristine (VCR)Control 1
TopotecanControl 2

Trial Purpose

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).

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
TestExperimentalLurbinectedin (PM01183) / Doxorubicin
  • Lurbinectedin (PM01183)
  • Doxorubicin (DOX)
    Control 1Active ComparatorCAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
      • Doxorubicin (DOX)
      • Cyclophosphamide (CTX)
      • Vincristine (VCR)
      Control 2Active ComparatorTopotecan
              • Topotecan

      Eligibility 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. (Small cell carcinomas of UK primary site are allowed provided Ki-67/MIB1 is expressed in >50% of tumor cells by IHC)

      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

      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

      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Both
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Progression-free survival (PFS)
      Time Frame:Every six weeks up to progression disease (aprox. 5 months)
      Safety Issue:No
      Description:

      Secondary Outcome Measures

      Measure:Overall survival (OS)
      Time Frame:Every three months up to death or study termination (aprox. 10 months)
      Safety Issue:No
      Description:
      Measure:Overall survival rate 12, 18 & 24 months
      Time Frame:Every three months up to death or study termination (aprox. 24 months)
      Safety Issue:No
      Description:

      Trial Keywords