Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05599685

Reclutamento in corso

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

Osservazionale

Fase non elencata

Local Institution - 0001

Sponsor: Bristol Myers Squibb

Ultimo Aggiornamento: 1 dicembre 2023
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Categoria di Trattamento

Mutazioni richieste

Nessuno

Studio Iniziato

19 ottobre 2022

Ultimo Aggiornamento dello Sponsor

1 dicembre 2023

Completamento Stimato

30 giugno 2027

Contatto dello studio

Nome:BMS Study Connect Contact Center www.BMSStudyConnect.com

Email:Clinical.Trials@bms.com

Telefono:855-907-3286

Nome:First line of the email MUST contain the NCT# and Site #.

Idoneità

Criteri di Inclusione

* 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.

Criteri di Esclusione

* 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.

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoN/A

MascheramentoN/A

Numero da Arruolare150

Bracci e Interventi

Bracci

Interventi

Tipo:

Descrizione:

Interventi:

Misure di Esito

Misure di Esito Primarie

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

Number of NIVO/IPI/PBC doses administered in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression levelUp to 157 weeks

Time interval between infusions in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression levelUp to 157 weeks

Rate of dose modifications in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression levelUp to 157 weeks

Rate of permanent treatment discontinuation in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression levelUp 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 levelUp 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 levelUp to 157 weeks

Relative dose intensity (RDI) in the overall study population and the subpopulations per NSCLC histological subtype and PD-L1 expression levelUp to 157 weeks

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]

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 levelUp 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 levelUp 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 level12, 24, and 36 months

Misure di Esito Secondarie

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 level12, 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 subpopulations12, 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 subpopulations12, 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 subpopulationsUp 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 subpopulationsUp to 157 weeks

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 levelUp to 157 weeks

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 levelUp to 157 weeks

Exposure-adjusted incidence rate (EAIR) of the following types of treatment-related AEs in the overall study populationUp to 157 weeks

Select irAEs: Immune-related pneumonitis, immune-related colitis, immune-related hepatitis, immune-related nephritis and renal dysfunction, immune-related endocrinopathies (hyperthyroidism, hypothyroidism, adrenal insufficiency, hypophysitis, diabetes mellitus and diabetic ketoacidosis), and immune-related skin adverse reactions (rash, Stevens-Johnson syndrome, toxic epidermal necrolysis. Other irAEs: Severe infusion reactions, pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, myasthenia gravis, myasthenic syndrome, aseptic meningitis, encephalitis, gastritis, sarcoidosis, duodenitis, myositis, myocarditis, and rhabdomyolysis, Vogt-Koyanagi-Harada syndrome, hypoparathyroidism, cystitis noninfective; and Other treatment-related AEs.

Severity (grade) of the following types of treatment-related AEs in the overall study populationUp to 157 weeks

Seriousness of the following types of treatment-related AEs in the overall study populationUp to 157 weeks

Outcome of the following types of treatment-related AEs in the overall study populationUp to 157 weeks

Action taken with study treatment of the following types of treatment-related AEs in the overall study populationUp to 157 weeks

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Siti dello Studio

Questo studio ha 1 sito

Local Institution - 0001

Athens, GR

Nome:Site 0001

In fase di reclutamento

Athens, 15561 GR

Local Institution - 0001

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