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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-11

Study Completion Date

2030-10-11

Brief Summary

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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

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants receiving first-line nivolumab plus ipilimumab

Nivolumab + ipilimumab

Intervention Type DRUG

As per product label

Interventions

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Nivolumab + ipilimumab

As per product label

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No