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

NCT05599685 | Completed

• 1 other identifier: CA209-6PK
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small-cell lung cancer; NSCLC; nivolumab; ipilimumab; platinum-based chemotherapy

Outcome Measures

Primary Outcomes (11)

• Baseline participant and disease characteristics of interest in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Baseline

• Number of NIVO/IPI/PBC doses administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Time interval between infusions in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Rate of dose modifications in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Rate of permanent treatment discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Frequencies of reasons for dose modifications/discontinuations in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Cumulative dose of NIVO and IPI administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Relative dose intensity (RDI) in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  RDI (%) will be calculated as follows: For NIVO: \[Cumulative dose (mg)/((Last Nivolumab dose date - Nivolumab Start dose date + 21) x 360/21)\] x 100\] For IPI: \[Cumulative dose (mg)/((Last Ipilimumab dose date - Ipilimumab Start dose date + 21) x 360/21)\] x 100\]

  Up to 157 weeks

• Proportion of participants receiving ≥90% RDI of NIVO and IPI in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Time from NIVO/IPI/PBC initiation until discontinuation due to any reason in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  Up to 157 weeks

• Proportions of participants surviving at the landmark timepoints of 12, 24, and 36 months after NIVO/IPI/PBC initiation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  12, 24, and 36 months

Secondary Outcomes (12)

• Proportions of participants who have not progressed or died from any cause at 12, 24, and 36 months after NIVO/IPI/PBC initiation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level

  12, 24, and 36 months

• Proportions of participants with an investigator-assessed best overall response (BOR) of either a confirmed complete response (CR) or partial response (PR) after NIVO/IPI/PBC initiation in the overall population and the NSCLC and PD-L1 subpopulations

  12, 24, and 36 months

• Proportions of participants with an investigator-assessed BOR of a confirmed CR, PR, or stable disease (Disease Control Rate (DCR)) after NIVO/IPI/PBC initiation in the overall study population and the NSCLC and PD-L1 subpopulations

  12, 24, and 36 months

• Time from start of NIVO/IPI/PBC treatment to the first documented investigator-assessed response (CR or PR), among participants who achieved at least PR in the overall study population and the NSCLC and PD-L1 subpopulations

  Up to 157 weeks

• Time from first documented response to progression or death due to any cause in the absence of progression (Kaplan Meier DoR), among participants who achieved at least PR in the overall study population and the NSCLC and PD-L1 subpopulations

  Up to 157 weeks

Study Arms (1)

Participants with metastatic NSCLC initiated on 1L treatment with NIVO/IPI/PBC

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

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Athens, 15561, Greece

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

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: October 26, 2022
• First Posted: October 31, 2022
• Study Start: October 19, 2022
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

GR (1)