A Study in Participants With First-Line Nivolumab Plus Ipilimumb Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— FINN  

Official title:

A German, Nationwide, Prospective, Observational, Multicenter Study in Patients With First-line Nivolumab Plus Ipilimumab Therapy Combined With Two Cycles of Chemotherapy for Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794010
• Other study ID #: CA209-7MA
• Status: Recruiting
• Start date: December 22, 2020
• Est. completion date: December 22, 2027

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to collect real-life data during the early post-market authorization approval period in Germany.

The study aims at describing the outcomes, patient characteristics, safety profile, treatment patterns and patient-reported Quality of Life of first-line treatment with nivolumab plus ipilimumab in combination with two cycles of chemo therapy in participants with confirmed stage IV Non-Small Cell Lung Cancer (NSCLC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: December 22, 2027
• Est. primary completion date: December 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of stage IV Non-Small Cell Lung Cancer (NSCLC) (histologically or cytologically confirmed stage), without known Epidermal Growth Factor Receptor (EGFR)- or Anaplastic Lymphoma Kinase (ALK)-alterations (according to label approved by EU)

• Decision to initiate a first-line treatment with nivolumab plus ipilimumab combined with two cycles of chemotherapy for the treatment of NSCLC according to the German label has been made independently of the study

Exclusion Criteria:

• Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment

• Participants with known EGFR- or ALK-alterations

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Local Institution - 0001	Leipzig

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)		Up to 5 years
Secondary	Overall Survival (OS) according to subgroups of interest		Up to 5 years
Secondary	Progression-free survival (PFS)		Up to 5 years
Secondary	Duration of treatment		Up to 5 years
Secondary	Distribution of socio-demographic characteristics of participants	Age, Sex, Ethnicity, Height, Weight and BMI	At Baseline
Secondary	Distribution of clinical characteristics of participants	Histology subtype, Tumor stage, Location or primary tumor and Location of metastases	At Baseline
Secondary	Description of participant-reported outcomes (PROs) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires		Up to 5 years
Secondary	Description of participant-reported outcomes (PROs) of participants using Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)		Up to 5 years
Secondary	Management of AEs: Treatment of AEs		Up to 5 years
Secondary	Management of AEs: Date of occurrence of AE		Up to 5 years
Secondary	Management of AEs: Start of treatment		Up to 5 years
Secondary	Treatment Patterns: Previous therapies		Up to 5 years
Secondary	Treatment Patterns: Subsequent therapies		Up to 5 years
Secondary	Treatment patterns: Concomitant medication		Up to 5 years
Secondary	Treatment patterns : Management of treatment-related adverse events [AEs], previous and subsequent therapies		Up to 5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls