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

Recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Nivolumab + ipilimumab

• Registration Number: NCT06487156
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2024-06-06
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2030-10-11
• Study Completion: 2030-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving first-line nivolumab plus ipilimumab	Nivolumab + ipilimumab	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 5 years
Treatment regimen	Up to 5 years
Number of participants discontinuing treatment	Up to 5 years
Participant clinical characteristics	Baseline and 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
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) results	Baseline and 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
Duration of response (DOR)	Up to 5 years
European Quality of Life-5 Dimensions (EQ-5D) Score	Baseline and up to 5 years
Management of Adverse Events (AEs)	Up to 5 years
Participant socio-demographic characteristics	Baseline and up to 5 years
Time to response (TTR)	Up to 5 years
Stage IV or recurrent, not previously treated, squamous and non-squamous NSCLC as confirmed by histology and/or cytology test results	Baseline

Trial Locations

Locations (1)

Istituto Nazionale Tumori - IRCCS Fondazione G.Pascale; 🇮🇹 Napoli, Italy