A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT06487156 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1409
• Study Type: observational
• Target: 404
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Up to 5 years

Secondary Outcomes (15)

• Progression-free survival (PFS)

  Up to 5 years

• Overall response rate (ORR)

  Up to 5 years

• Best overall response (BOR)

  Up to 5 years

• Best overall response rate (BORR)

  Up to 5 years

• Tumor response to treatment as classified by the treating physician and Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  Up to 5 years

Study Arms (1)

Participants receiving first-line nivolumab plus ipilimumab

Drug: Nivolumab + ipilimumab

Interventions

Nivolumab + ipilimumab DRUG

As per product label

Participants receiving first-line nivolumab plus ipilimumab

Eligibility Criteria

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

Study Population

Adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer treated with nivolumab plus ipilimumab as first-line treatment

You may qualify if:

• Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
• Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
• Patient is at least 18 years of age at time of treatment decision
• Patient provided written informed consent to participate in the study

You may not qualify if:

• Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
• Patients with known EGFR- or ALK-alterations
• Previous treatment with nivolumab and/or ipilimumab
• Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Naples, 80131, Italy

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: June 6, 2024
• First Posted: July 5, 2024
• Study Start: October 11, 2023
• Primary Completion (Estimated): October 11, 2030
• Study Completion (Estimated): October 11, 2030
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)