Clinical Trial: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage

Brief Summary: This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.

Detailed Summary:
Sponsor: Istituto Oncologico Veneto IRCCS

Current Primary Outcome: Progression free survival (PFS) [ Time Frame: Approximately 48 months ]

PFS will be assessed From the date of enrollment to the date of first documented disease progression or to the date of death from any cause or to the date of a new anti‐cancer therapy, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: Approximately 48 months ]
    The survival status will be assessed every 12 weeks (±14 days) until 48 months. Patients alive at the time of analysis will be censored at the date of last assessment.
  • Disease control rate (DCR) [ Time Frame: Approximately 48 months ]
    The DCR will be defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) at enrollment until the final visit
  • Occurrence of all grade toxicity events assessed by CTCAE v4.0 [ Time Frame: Toxicity will be recorded during the treatment, until 30 days after the last dose of study medication, and graded according to the NCI‐ Common Terminology Criteria for Adverse Events (CTCAE) v.4. ]
    Toxicity will be analyzed in an "as treated" population, provided patients had received at least one dose of therapy.
  • Quality of Life [ Time Frame: Approximately 48 months ]
    The instruments used for assessing the quality of life are the EORTC QLQ‐C30 and QLQ‐LC13 questionnaires. Quality of Life will be assessed from the date of enrollment until the end of treatment visit, that is anticipated after maximum 48 months.


Original Secondary Outcome: Same as current

Information By: Istituto Oncologico Veneto IRCCS

Dates:
Date Received: November 10, 2015
Date Started: October 2015
Date Completion: October 2019
Last Updated: October 5, 2016
Last Verified: October 2016