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
← catalyst calendarNCT05161325 · readout in 134 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With Ono Pharma USA Inc.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
525actual
Sites
1
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-12-15 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2021-12-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small Cell Lung Cancer
Primary outcomes
what the primary-completion date above is the date OFDuration of treatment
measured Up to 1 year
Rates of participants with second-line treatment
measured Up to 1 year
Overall survival (OS)
measured 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]
measured Up to 1 year
Time to next treatment [(TNT)
measured Up to 1 year
Treatment-free survival (TFS)
measured Up to 1 year
Treatment continuation rate
measured Up to 1 year
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation
measured Up to 1 year
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