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

Active, not recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT04794010
• Lead Sponsor: Bristol-Myers Squibb

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-12-22
• Study Completion: 2027-12-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 825

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇩🇪 Leipzig, Germany