Clinical trial NCT05599685: A Study of Nivolumab, Ipilimumab, and Chemotherapy in Participants With Non-small Cell Lung Cancer
Official title: A Non-interventional, Multicenter, Prospective stUdy to Record Treatment patteRns of nivOlumab+Ipilimumab+chemotheRapy Combination as First Line treAtment of Metastatic NSCLC in Routine Clinical Practice in Greece - the 'AURORA' Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small-cell lung cancer
NSCLC
nivolumab
ipilimumab
platinum-based chemotherapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: Baseline participant and disease characteristics of interest in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Baseline
measure: Number of NIVO/IPI/PBC doses administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Time interval between infusions in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Rate of dose modifications in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Rate of permanent treatment discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Frequencies of reasons for dose modifications/discontinuations in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Cumulative dose of NIVO and IPI administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Relative dose intensity (RDI) in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: 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
timeFrame: Up to 157 weeks
measure: 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
timeFrame: Up to 157 weeks
measure: 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
timeFrame: 12, 24, and 36 months
Secondary outcomes:
measure: 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
timeFrame: 12, 24, and 36 months
measure: 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
timeFrame: 12, 24, and 36 months
measure: 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
timeFrame: 12, 24, and 36 months
measure: 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
timeFrame: Up to 157 weeks
measure: 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
timeFrame: Up to 157 weeks
measure: Types of next treatment planned to be administered for NSCLC after NIVO/IPI/PBC discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Frequencies of next treatment planned to be administered for NSCLC after NIVO/IPI/PBC discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression level
timeFrame: Up to 157 weeks
measure: Exposure-adjusted incidence rate (EAIR) of the following types of treatment-related AEs in the overall study population
timeFrame: Up to 157 weeks
measure: Severity (grade) of the following types of treatment-related AEs in the overall study population
timeFrame: Up to 157 weeks
measure: Seriousness of the following types of treatment-related AEs in the overall study population
timeFrame: Up to 157 weeks
measure: Outcome of the following types of treatment-related AEs in the overall study population
timeFrame: Up to 157 weeks
measure: Action taken with study treatment of the following types of treatment-related AEs in the overall study population
timeFrame: Up to 157 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: