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

Non-Small Cell Lung Cancer Clinical Trial

— ENLARGE-Lung  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910999
• Other study ID #: CA209-580
• Status: Completed
• Start date: August 9, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Germany	Local Institution - 0001	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   BMS Clinical Trial Information