A Study of Effectiveness and Safety of the First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy for Advanced/Recurrent Non-Small Cell Lung Cancer in Japan

Study Overview
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Brief Summary
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The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan.

Official Title
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An Observational Study of Effectiveness and Safety of the First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy for Advanced/Recurrent Non-Small Cell Lung Cancer in Japan

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histologically confirmed advanced or recurrent NSCLC Participants who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to November 30, 2021. Pemetrexed plus cisplatin or carboplatin for participants with non- squamous histology and paclitaxel plus carboplatin for participants with squamous histology are only acceptable combinations of chemotherapy. Exclusion Criteria: In participants with non-squamous histology, participants who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated. Participants who had antineoplastic treatment as first-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy. However, participants who correspond to a) or b) below will be included in this study. Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy. Participants who are received or have received bisphosphonates or denosumab for bone metastasis Participants who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards. Participants who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC Other participants who are judged by the investigators to be inappropriate for enrollment in this study Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with untreated advanced or recurrent non-small cell lung cancer (NSCLC) receiving first-line nivolumab plus ipilimumab with or without chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment | Time from the initiation date of nivolumab plus ipilimumab with or without chemotherapy among eligible participants to the last date of treatment as an event. | Up to 1 year | 
| Rates of participants with second-line treatment | The rate of eligible participants who have completed nivolumab plus ipilimumab with or without chemotherapy during the observation period and have initiated second-line treatment | Up to 1 year | 
| Overall survival (OS) | Defined as the time between the date of initiation of nivolumab plus ipilimumab with or without chemotherapy and the date of death from any cause among eligible participants. | Up to 1 year | 
| Incidence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 Grade 3 or higher immune-related adverse events [irAEs] |  | Up to 1 year | 
| Time to next treatment [(TNT) | Defined as the time between the date of combination therapy with nivolumab plus ipilimumab with or without chemotherapy initiation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first. | Up to 1 year | 
| Treatment-free survival (TFS) | Defined as the time between the date of nivolumab plus ipilimumab with or without chemotherapy cessation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first. | Up to 1 year | 
| Treatment continuation rate | The rate of eligible participants who have continued nivolumab plus ipilimumab with or without chemotherapy during the observation period. | Up to 1 year | 
| Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1 |  | Up to 1 year | 
| Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1 |  | Up to 1 year | 
| Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1 |  | Up to 1 year | 
| Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1 |  | Up to 1 year | 
| Overall Survival (OS) by patient background |  | Up to 1 year | 
| Time to next treatment (TNT) by patient background |  | Up to 1 year | 
| Treatment-free survival (TFS) by patient background |  | Up to 1 year | 
| Treatment continuation rate by patient background |  | Up to 1 year | 
| Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background |  | Up to 1 year | 
| Incidence of TRAEs leading to treatment discontinuation by patient background |  | Up to 1 year | 
| Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Incidence of CTCAE v 5.0 Grade 3 or higher irAEs of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors |  | Up to 1 year | 
| Time to onset of immune-related adverse events (irAEs) to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness |  | Up to 1 year | 
| Duration of treatment of second-line treatment |  | Up to 1 year | 
| Reasons for treatment discontinuation of second-line treatment |  | Up to 1 year | 
| Treatment related death of second-line treatment |  | Up to 1 year | 
| Response rate of second-line treatment |  | Up to 1 year | 
| Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days |  | Up to 1 year | 
| Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days |  | Up to 1 year | 
| Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days |  | Up to 1 year | 
| Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days |  | Up to 1 year | 
| Duration of treatment of second-line treatment in participants with disease progression within 90 days |  | Up to 1 year | 
| Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days |  | Up to 1 year | 
| Overall survival of second-line treatment in participants with disease progression within 90 days |  | Up to 1 year | 
| Response rate of second-line treatment in participants with disease progression within 90 days |  | Up to 1 year | 
| Treatment related death of second-line treatment in participants with disease progression within 90 days |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-936558, ONO-4538, Nivolumab, Ipilimumab, Retrospective, Observational