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

NCT04794010 | Active Not Recruiting

• 1 other identifier: CA209-7MA
• Study Type: observational
• Target: 825
• Locations: 1 country
• Sites: 1

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).

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer; NSCLC; Nivolumab; Ipilimumab; Chemotherapy; Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Up to 5 years

Secondary Outcomes (14)

• Overall Survival (OS) according to subgroups of interest

  Up to 5 years

• Progression-free survival (PFS)

  Up to 5 years

• Duration of treatment

  Up to 5 years

• Distribution of socio-demographic characteristics of participants

  At Baseline

• Distribution of clinical characteristics of participants

  At Baseline

Study Arms (1)

Cohort 1

Participants with Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It is planned to include 825 patients at 100 sites in Germany in this observational study from marketing authorization by the European Medicines Agency (EMA) onwards. The planned recruitment phase is approximately 24 months, the planned follow-up phase 60 months from the day of nivolumab plus ipilimumab plus two cycles of chemotherapy initiation (D0).

You may qualify if:

• 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

You may not qualify if:

• Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
• Participants with known EGFR- or ALK-alterations

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Leipzig, 04277, Germany

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 11, 2021
• Study Start: December 22, 2020
• Primary Completion (Estimated): December 22, 2027
• Study Completion (Estimated): December 22, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

DE (1)