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Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

NCT02566993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 613

Last updated 2021-10-28

Study results available
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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.

Conditions

  • Small-cell Lung Cancer

Interventions

DRUG

Lurbinectedin (PM01183)

DRUG

Doxorubicin (DOX)

DRUG

Cyclophosphamide (CTX)

DRUG

Vincristine (VCR)

DRUG

Topotecan

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-30
Primary Completion
2020-02-24
Completion
2020-02-24

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lebanon
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566993 on ClinicalTrials.gov