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
NCT ID: NCT05161325
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
525 participants
OBSERVATIONAL
2020-12-15
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1
Participants with untreated advanced or recurrent non-small cell lung cancer (NSCLC) receiving first-line nivolumab plus ipilimumab with or without chemotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
1. 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
* 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.
1. Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
2. 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
20 Years
ALL
No
Sponsors
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Ono Pharma USA Inc
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Minato-ku, Tokyo, Japan
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-64A
Identifier Type: -
Identifier Source: org_study_id
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