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OpenTrials
Completed

NCT Number: NCT03804554

A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab

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Key information

Conditions

Non-small Cell Lung Cancer 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

Local Institution

Heidelburg, Victoria, 3084, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult male or female (≥18 years of age) patients with NSCLC
  • Treated with nivolumab on the Australian PAP
  • Initiated Nivolumab between May 2015 and August 2017
  • Attending clinician agreeable to provide patient data
  • Local institutional ethics requirements satisfied

Exclusion criteria

  • Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Time to treatment failure (TTF)

    Time frame: Approximately 27 months

Secondary outcomes

  1. Best overall response (BOR)

    Time frame: Approximately 27 months

  2. Progression free survival rate (PFSR)

    Time frame: Approximately 27 months

  3. Overall survival rate (OSR)

    Time frame: Approximately 27 months

  4. Incidence of AE's

    Time frame: Approximately 27 months

  5. Incidence of SAE's

    Time frame: Approximately 27 months

  6. Reasons for ceasing treatment

    Time frame: Approximately 27 months

    Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death

  7. Incidence of patients with brain metastases

    Time frame: Approximately 27 months

  8. Incidence of re-treatment

    Time frame: Approximately 27 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
May 27, 2022

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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