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Trial record 1 of 1 for:    PM1183-C-003-14
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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 (ATLANTIS)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT02566993
First received: September 24, 2015
Last updated: June 22, 2017
Last verified: January 2017
  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: No masking
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02566993

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

  Show 136 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
Study First Received: September 24, 2015
Last Updated: June 22, 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
Doxorubicin
Liposomal doxorubicin
Cyclophosphamide
Vincristine
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on June 23, 2017