A Study of Nivolumab, Ipilimumab, and Chemotherapy in Participants With Non-small Cell Lung Cancer

Trial Title: A Study of Nivolumab, Ipilimumab, and Chemotherapy in Participants With Non-small Cell Lung Cancer

NCT ID: NCT05599685

Condition: Carcinoma, Non-Small-Cell Lung

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-small-cell lung cancer
NSCLC
nivolumab
ipilimumab
platinum-based chemotherapy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: The purpose of this study is to describe the real-world patient and disease characteristics of metastatic non-small cell lung cancer (NSCLC) participants initiated on first-line (1L) treatment with nivolumab, ipilimumab, and platinum-based chemotherapy (NIVO/IPI/PBC), in the overall study population and the subpopulations per histological subtype of NSCLC and PD-L1 expression level.

Criteria for eligibility:

Study pop:
Participants with metastatic non-small cell lung cancer initiated on first-line treatment with nivolumab, ipilimumab, and platinum-based chemotherapy

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Participants with histologically- or cytologically-confirmed diagnosis of metastatic NSCLC (of any histological subtype) whose tumors have no sensitizing EGFR mutation or ALK translocation. - Participants who have been initiated on 1L treatment with NIVO/IPI/PBC (nivolumab combined with ipilimumab and 2 cycles of PBC) as per the products' Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom the treatment regimen is ongoing and no more than one nivolumab infusion has been administered from treatment initiation to obtaining the signed informed consent. - Participants for whom the decision to prescribe treatment with NIVO/IPI/PBC has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the participant in the current study. Exclusion Criteria: - Participants with a current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment. - Participants who have been treated with any prior systemic therapy in the metastatic setting of NSCLC. - Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to NIVO/IPI/PBC therapy initiation.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Local Institution - 0001

Address:
City: Athens
Zip: 15561
Country: Greece

Status: Recruiting

Contact:
Last name: Site 0001

Start date: October 19, 2022

Completion date: June 30, 2027

Lead sponsor:
Agency: Bristol-Myers Squibb
Agency class: Industry

Source: Bristol-Myers Squibb

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05599685
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm