An observational study in Non-Small Cell Lung Cancer (NSCLC), sponsored by Hoffmann-La Roche. Completed at 94 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Hoffmann-La Roche · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 358 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Retrospective Inclusion:
Exclusion Criteria:
Patients not eligible for Atezolizumab treatment according to SmPC
Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab
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).
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).
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)
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)
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)
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)
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)
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)
Best overall response of patients in cohort 2 ("Coh2 BOR")
Time frame: Baseline through the end of study (approximately 5 years)
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).
Percentage of participants with Adverse Events (AEs)
Time frame: Baseline through the end of study (approximately 5 years)
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)
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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