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
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT05161325
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 525
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Histologically confirmed advanced or recurrent NSCLC
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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.
- 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.
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Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
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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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Treatment continuation rate Up to 1 year The rate of eligible participants who have continued nivolumab plus ipilimumab with or without chemotherapy during the observation period.
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation Up to 1 year Time to next treatment [(TNT) Up to 1 year 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.
Overall survival (OS) Up to 1 year 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.
Treatment-free survival (TFS) Up to 1 year 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.
Rates of participants with second-line treatment Up to 1 year 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
Duration of treatment Up to 1 year 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.
- Secondary Outcome Measures
Name Time Method 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 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 Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors 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 Reasons for treatment discontinuation of second-line treatment 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 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 continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days Up to 1 year Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1 Up to 1 year Treatment-free survival (TFS) 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 Response rate of second-line treatment Up to 1 year Treatment related death of second-line treatment in participants with disease progression within 90 days 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 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 Treatment related death of second-line treatment Up to 1 year Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days Up to 1 year Treatment continuation rate by patient background Up to 1 year Treatment-free survival 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 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 Duration of treatment of second-line treatment in participants with disease progression within 90 days Up to 1 year
Trial Locations
- Locations (1)
Local Institution
🇯🇵Minato-ku, Tokyo, Japan