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The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03559647
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
Hyperion Is A Prospective, Multicenter, Non-Interventional, Two-Cohort Study Collecting Primary Data In Patients With Locally Advanced Or Metastatic NSCLC Of Squamous Or Non-Squamous Histology After Prior Chemotherapy Being Treated With Atezolizumab In Routine Clinical Practice.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer (NSCLC) Drug: Atezolizumab

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Study Type : Observational
Estimated Enrollment : 1380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : May 12, 2023
Estimated Study Completion Date : July 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Cohort 1
Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab
Cohort 2
Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab
Drug: Atezolizumab
Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).




Primary Outcome Measures :
  1. Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment [ Time Frame: Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years). ]
  2. Duration of response (DOR) to Atezolizumab treatment [ Time Frame: Time from first documentation of complete response (CR) or partial response (PR), whichever occurs first, until progressive disease (PD), as evaluated by the physician according to routine practice or death; through the end of study (~ 5 years) ]

Secondary Outcome Measures :
  1. Disease control rate (DCR) of overall population [ Time Frame: Percentage of patients who achieved a CR, a PR, or stable disease (SD) as evaluated by the physician according to clinical practice at the time of the fifth Atezolizumab infusion; (until the end of study, approximately 5 years) ]
  2. Progression-free survival (PFS) of overall population [ Time Frame: Time from initiation of study treatment to the first occurrence of progressive disease (PD) or death from any cause, whichever occurs first, as evaluated by the physician according to clinical practice, through the end of study (approximately 5 years) ]
  3. Time to response (TTR) of overall population [ Time Frame: Time from first dose to first response as assessed in clinical routine, through the end of study (approximately 5 years) ]
  4. Overall response rate (ORR) of overall population [ Time Frame: Rate of CR and PR in patients as assessed in clinical routine, through end of study (approximately 5 years) ]
  5. Best overall response (BOR) of overall population [ Time Frame: Best response achieved within 12 weeks as assessed in clinical routine, through the end of study (approximately 5 years) ]
  6. Best overall response of patients in cohort 2 ("Coh2 BOR") [ Time Frame: Baseline through the end of study (approximately 5 years) ]
  7. Overall survival of cohort 2 ("Coh2 OS") [ Time Frame: Time from initiation of Atezolizumab treatment to death from any cause (until the end of study, approximately 5 years). ]
  8. Percentage of participants with Adverse Events (AEs) [ Time Frame: Baseline through the end of study (approximately 5 years) ]

Other Outcome Measures:
  1. Health-related quality of life (HRQoL) [ Time Frame: Prior to first Atezolizumab infusion, during Atezolizumab treatment, and post Atezolizumab discontinuation, through the end of study (approximately 5 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible are participants with locally advanced or metastatic NSCLC after prior chemotherapy, who have been chosen by their treating physicians to receive atezolizumab according to the current Summary of Product Characteristics (SmPC) of TECENTRIQ
Criteria

Inclusion Criteria:

  • Diagnosis of locally advanced or metastatic NSCLC (histologically or cytologically confirmed stage IIIB/stage IV) and prior chemotherapy
  • Decision to be treated with Atezolizumab according to Summary of Product Characteristics (SmPC) by treating physician, independent of this non-interventional study
  • No contraindication to treatment with Atezolizumab

Retrospective Inclusion:

  • Participants may be included retrospectively. Retrospective inclusion and documentation is limited to up to 9 weeks after initial start of therapy with Atezolizumab (corresponding to a maximum of 3 treatment cycles with drug administrations at 3-week intervals), corresponding to a maximum of 9 weeks prior to date of informed consent. Quality of life for this population will be captured and assessed retrospectively with a modified questionnaire for the period immediately prior to treatment start until study inclusion. participants who started Atezolizumab therapy more than 9 weeks prior to ICF being obtained may not be included in the study.
  • Participants who give consent to be retrospectively enrolled but have already discontinued Atezolizumab for reasons such as loss of clinical benefit or toxicity may also take part in the study, given their first administration of Atezolizumab is within 9 weeks of consenting to take part, and they meet all other eligibility criteria.

Exclusion Criteria:

Patients not eligible for Atezolizumab treatment according to SmPC


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559647


Contacts
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Contact: Reference Study ID Number: ML39885 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03559647     History of Changes
Other Study ID Numbers: ML39885
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs