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

May 10, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

868

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
NSCLC patients with squamous tumor histology
NSCLC patients with non-squamous tumor histology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Approximately 5 years
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: Approximately 5 years
Approximately 5 years
Best Overall Response (BOR)
Time Frame: Approximately 5 years
Approximately 5 years
Best Overall Response Rate (BORR)
Time Frame: Approximately 5 years
Approximately 5 years
Overall Response Rate (ORR)
Time Frame: Approximately 5 years
Approximately 5 years
Duration of Response (DOR)
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of socio-demographic characteristics in adult patients diagnosed with advanced NSCLC
Time Frame: At baseline and for up to 5 years
At baseline and for up to 5 years
Distribution of clinical characteristics in adult patients diagnosed with advanced NSCLC
Time Frame: At baseline and for up to 5 years
At baseline and for up to 5 years
Distribution of treatment patterns in adult patients diagnosed with advanced NSCLC
Time Frame: At baseline and for up to 5 years
At baseline and for up to 5 years
Distribution of Incidence of All Adverse Events (AEs)
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of Severity of All Adverse Events (AEs)
Time Frame: Approximately 5 years
Approximately 5 years
Distribution of Management of All Adverse Events (AEs)
Time Frame: Approximately 5 years
Approximately 5 years
European Quality of Life-5 Dimensions (EQ-5D)
Time Frame: At baseline and for up to 5 years
At baseline and for up to 5 years
Lung Cancer Symptom Scale (LCSS)
Time Frame: At baseline and for up to 5 years
At baseline and for up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2016

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimated)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe