ClinicalTrials.Veeva

Menu

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

Roche logo

Roche

Status

Completed

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Treatments

Drug: Atezolizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT03559647
ML39885

Details and patient eligibility

About

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.

Enrollment

358 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

358 participants in 2 patient groups

Cohort 1
Description:
Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab
Cohort 2
Description:
Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab
Treatment:
Drug: Atezolizumab

Trial contacts and locations

94

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems