Clinical Trial 19320

Cancer Type: Thoracic
Interventions:Atezolizumab (Tecentriq)

Study Type: Treatment
Phase of Study: NA
Investigators:

  • Scott Antonia

Overview

Study Title

An Open-Label, Multicenter Extension Study In Patients Previously Enrolled In A Genentech and/or F Hoffmann La Roche Ltd. Sponsored Atezolizumab Study

Summary

The purpose of this study is to find out what effects, good or bad, atezolizumab alone or atezolizumab combined with other agent(s) or comparator agent(s) have on participants and their cancer and to provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible participants who were previously enrolled and treated in a parent study.

Objective

To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure

Inclusion Criteria

  • Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study
  • First dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study
  • Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
  • Will comply with contraception criteria detailed in the designated Referenced Safety Information (RSI)
  • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

  • Exclusion Criteria

  • Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
  • Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period allowed in the parent study
  • Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
  • Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
  • Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
  • Ongoing Serious Adverse Event(s) (SAE(s)) that has not resolved to baseline level or Grade less than or equal to (> Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the participant at high risk for treatment-related complications
  • Concurrent participation in any therapeutic clinical trial (other than the parent study)