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Completed

NCT Number: NCT02910999

Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy

This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.

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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 - 0001

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
  • Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
  • Males and Females, ≥18 years of age

Exclusion criteria

  • Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
  • Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
  • Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 5 years

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Approximately 5 years

  2. Overall Response Rate (ORR)

    Time frame: Approximately 5 years

  3. Best Overall Response Rate (BORR)

    Time frame: Approximately 5 years

  4. Best Overall Response (BOR)

    Time frame: Approximately 5 years

  5. Duration of Response (DOR)

    Time frame: Approximately 5 years

  6. Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC

    Time frame: At baseline and for up to 5 years

  7. Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC

    Time frame: At baseline and for up to 5 years

  8. Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC

    Time frame: At baseline and for up to 5 years

  9. Distribution of Incidence of All Adverse Events (AEs)

    Time frame: Approximately 5 years

  10. Distribution of Severity of All Adverse Events (AEs)

    Time frame: Approximately 5 years

  11. Distribution of Management of All Adverse Events (AEs)

    Time frame: Approximately 5 years

  12. European Quality of Life-5 Dimensions (EQ-5D)

    Time frame: At baseline and for up to 5 years

  13. Lung Cancer Symptom Scale (LCSS)

    Time frame: At baseline and for up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology (Stage IIIB/IV) After Prior Chemotherapy

Acronym: ENLARGE-Lung

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2016
Registry last updated
May 13, 2024

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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