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

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT02910999
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-09
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 868

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Approximately 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Frankfurt, Germany