Clinical trial · Observational
The Effectiveness Of Atezolizumab In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Locally-Advanced Or Metastatic Non-Small Cell Lung Cancer After Prior Chemotherapy
NCT03559647CI-TRIAL-00069275completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Participants who have demonstrated a lack of Clinical Benefit from Atezolizumab
- label
- Cohort 2
- description
- Participants who demonstrated durability of Clinical Benefit and Tumor Response to Atezolizumab
- interventionNames
- Drug: Atezolizumab
Primary outcomes (2)
- measure
- Time to loss of clinical benefit (TTLCB) from Atezolizumab treatment
- timeFrame
- Time from first dose to loss of clinical benefit as assessed by the treating physician, through the end of study (approximately 5 years).
- measure
- Duration of response (DOR) to Atezolizumab treatment
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDReinmuth N, Gessner C, Schichtl T, Schutte W, Hammerschmidt S, Schulz H, Zortel M, Zerbes R, Reck M. Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION. Cancer Treat Res Commun. 2025;43:100878. doi: 10.1016/j.ctarc.2025.100878. Epub 2025 Feb 10. PMID 40023002