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NCT Number: NCT03559647

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2018
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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