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Trial record 4 of 264 for:    ATLANTIS

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)

This study is currently recruiting participants.
Verified January 2017 by PharmaMar
Sponsor:
ClinicalTrials.gov Identifier:
NCT02566993
First Posted: October 2, 2015
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaMar
  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).

Condition Intervention Phase
Small-cell Lung Cancer Drug: Lurbinectedin (PM01183) Drug: Doxorubicin (DOX) Drug: Cyclophosphamide (CTX) Drug: Vincristine (VCR) Drug: Topotecan Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by PharmaMar:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Every six weeks up to progression disease (aprox. 5 months) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 600
Study Start Date: July 2016
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Lurbinectedin (PM01183) / Doxorubicin
Drug: Lurbinectedin (PM01183) Drug: Doxorubicin (DOX)
Active Comparator: Control 1
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
Drug: Doxorubicin (DOX) Drug: Cyclophosphamide (CTX) Drug: Vincristine (VCR)
Active Comparator: Control 2
Topotecan
Drug: Topotecan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566993


Contacts
Contact: Pharma Mar Clinical Oncology Department clinicaltrials@pharmamar.com

  Show 151 Study Locations
Sponsors and Collaborators
PharmaMar
  More Information

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02566993     History of Changes
Other Study ID Numbers: PM1183-C-003-14
First Submitted: September 24, 2015
First Posted: October 2, 2015
Last Update Posted: November 17, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Vincristine
Topotecan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators