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  • DIV-SCLC-301

    Acronym: 

    DISTINCT

    ACTRN/NCT /ethics: 

    NCT03098030

    Scientific title: 

    Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

    Summary of trial and patient characteristics

    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase Phase II, Phase III Tumour Stream Small Cell Lung Cancer
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2017-06-01
    Molecular Target Anticipated End Date
    Cancer Type Lung & mesothelioma
    Trial Type Treatment
    Phase Phase II, Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Small Cell Lung Cancer
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2017-06-01
    Anticipated End Date

    Trial Summary

    This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or =3 months).

    Lay Summary

    Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

    Sponsor / Cooperative group

    United Therapeutics

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Nimit Singhal Recruiting
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting