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A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice (IMreal)

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ClinicalTrials.gov Identifier: NCT03782207
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date November 28, 2018
First Posted Date December 20, 2018
Last Update Posted Date January 9, 2020
Actual Study Start Date February 7, 2019
Estimated Primary Completion Date June 2, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2018)
  • Overall Survival (OS) [ Time Frame: Index date up to approximately 5 years ]
    Time from index date until date of death from any cause. Index date is the date of administration of the first ever dose of atezolizumab for each patient.
  • OS at 2 Years [ Time Frame: After index date up to 2 years ]
    Percentage of participants alive 2 years after initiation of atezolizumab treatment.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03782207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
  • Time to Loss of Clinical Benefit (TTLCB) [ Time Frame: Index date up to approximately 5 years ]
    Time from the index date to loss of clinical benefit as assessed by the treating physician.
  • Progression Free Survival (PFS) [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to death or disease progression (PD).
  • Objective Response Rate (ORR) [ Time Frame: After index date up to approximately 5 years ]
    Percentage of participants who have a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). BOR for each participant is the best response achieved after the index date prior to initiation of any subsequent treatment.
  • Time to Response [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to first objective tumor response, CR or PR.
  • Duration of Response (DoR) [ Time Frame: Index date up to approximately 5 years ]
    Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.
  • Disease Control Rate (DCR) [ Time Frame: From 12 weeks after index date up to approximately 5 years ]
    Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.
  • Duration of DCR [ Time Frame: After index date up to approximately 5 years ]
    Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score [ Time Frame: Index date or after ICF signature, and approx. at 6, 12, and 24 weeks of treatment; and at the first visit after atezolizumab discontinuation, then at 3 months, 6 months and every 12 months thereafter until end of study (study planned duration 5 years) ]
    EQ-5D-5L during and after atezolizumab treatment will be used to assess HRQoL. Scale is from 1-5 (no problems, slight problems, moderate problems, severe problems and extreme problems).
  • WPAI-GH Score [ Time Frame: Index date or after ICF signature, and approx. at 6, 12, and 24 weeks of treatment; and at the first visit after atezolizumab discontinuation, then at 3 months, 6 months and every 12 months thereafter until end of study (study planned duration 5 years) ]
    Work Productivity and Activity Impairment Questionnaire General Health V2.0 (WPAI-GH) during and after atezolizumab treatment will be used to assess the ability to work. The WPAI-GH is a standardized questionnaire used to measure the impact of health on work performance. From the WPAI-GH, absenteeism (the percentage of work time missed), presenteeism (the percentage of time when working that productivity is impaired), overall work impairment (a combination of absenteeism and presenteeism), and total activity impairment (the percentage of impairment in daily activities) can be measured.
  • Number of Paricipants with Disease Stage TNM and IUCC [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.) ]
  • Number of Participants at Each Level of Karnofsky or ECOG Performance Status [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient. ]
  • Total Number of Infusions of Atezolizuamb [ Time Frame: Treatment period until discontinuation (up to approximately 5 years) ]
  • Duration of Treatment With Atezolizumab [ Time Frame: Index date until date of treatment discontinuation (up to approximately 5 years) ]
  • Time to initiation of subsequent cancer-related therapies [ Time Frame: Up to approximately 5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 5 years ]
Original Secondary Outcome Measures
 (submitted: December 18, 2018)
  • Time to Loss of Clinical Benefit (TTLCB) [ Time Frame: Index date up to approximately 5 years ]
    Time from the index date to loss of clinical benefit as assessed by the treating physician.
  • Progression Free Survival (PFS) [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to death or disease progression (PD).
  • Objective Response Rate (ORR) [ Time Frame: After index date up to approximately 5 years ]
    Percentage of participants who have a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). BOR for each participant is the best response achieved after the index date prior to initiation of any subsequent treatment.
  • Time to Response [ Time Frame: Index date up to approximately 5 years ]
    Time from index date to first objective tumor response, CR or PR.
  • Duration of Response (DoR) [ Time Frame: Index date up to approximately 5 years ]
    Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.
  • Disease Control Rate (DCR) [ Time Frame: From 12 weeks after index date up to approximately 5 years ]
    Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.
  • Duration of DCR [ Time Frame: After index date up to approximately 5 years ]
    Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.
  • EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score [ Time Frame: Index date or after ICF signature, and approx. at 6, 12, and 24 weeks of treatment; and at the first visit after atezolizumab discontinuation, then at 3 months, 6 months and every 12 months thereafter until end of study (study planned duration 5 years). ]
    EQ-5D-5L during and after atezolizumab treatment will be used to assess HRQoL. Scale is from 1-5 (no problems, slight problems, moderate problems, severe problems and extreme problems).
  • Number of Paricipants with Disease Stage TNM and IUCC [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.) ]
  • Number of Participants at Each Level of Karnofsky or ECOG Performance Status [ Time Frame: At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient. ]
  • Total Number of Infusions of Atezolizuamb [ Time Frame: Treatment period until discontinuation (up to approximately 5 years) ]
  • Duration of Treatment With Atezolizumab [ Time Frame: Index date until date of treatment discontinuation (up to approximately 5 years) ]
  • Time to initiation of subsequent cancer-related therapies [ Time Frame: Up to approximately 5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
Official Title A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
Brief Summary This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.
Detailed Description The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible patients receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC). The study may be amended for inclusion of new cohorts as these are approved in the participating countries. Participants will be included into each cohort based on their indication for receiving atezolizumab.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants diagnosed with la/mUC previously treated with platinum-containing chemotherapy, and participants diagnosed with la/m non-small cell lung cancer (NSCLC) after prior chemotherapy.
Condition
  • Urothelial Carcinoma
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
Intervention Drug: Atezolizumab
Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.
Other Name: Tecentriq
Study Groups/Cohorts
  • Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)
    Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy.
    Intervention: Drug: Atezolizumab
  • Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])
    Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy.
    Intervention: Drug: Atezolizumab
  • Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)

    EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy.

    FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.

    Intervention: Drug: Atezolizumab
  • Cohort 4 (ES-SCLC LOT1)
    Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated.
    Intervention: Drug: Atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2019)
2400
Original Estimated Enrollment
 (submitted: December 18, 2018)
1100
Estimated Study Completion Date June 2, 2025
Estimated Primary Completion Date June 2, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+mUC) or (2) As monotherapy for the treatment of adult patients with locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab (Cohort 2 LOT2+NSCLC) or (3) In combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC).
  • Patient is prescribed atezolizumab therapy for the first time.
  • Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.

Exclusion Criteria:

  • Patients not receiving treatment for a disease with atezolizumab according to standard of care and in line with the current summary of product characteristics (SPC) or local labelling. Cisplatin ineligible patients receiving atezolizumab LOT1 for the treatment of locally advanced/metastatic UC and TNBC patients will be excluded
  • Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date not part of locally approved combination therapy with atezolizumab.
  • Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of an access or compassionate use program.
  • Patients not receiving atezolizumab, but a biosimilar or non-original biologic.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Reference Study ID Number: MO40653 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries Argentina,   Austria,   Belgium,   Bulgaria,   Colombia,   France,   Hungary,   Israel,   Italy,   Lithuania,   Netherlands,   Philippines,   Poland,   Portugal,   Romania,   Slovenia,   Spain,   United Arab Emirates,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03782207
Other Study ID Numbers MO40653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2020