A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
← catalyst calendarNCT06946797 · readout in 170 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
76estimated
Sites
38
Countries
Brazil, Chile, France +6
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 | 2025-09-19 | actual | When the study began enrolling |
| Primary completion | 2027-02-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-25 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-14 | 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
Interventions
- Drug: Nivolumab — also filed as BMS-986298
- Drug: Ipilimumab — also filed as Yervoy
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Cisplatin
Primary outcomes
what the primary-completion date above is the date OFMaximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
measured Up to 3 weeks
Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum
measured Up to 3 weeks
Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum
measured Up to 3 weeks
Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum
measured Up to 3 weeks
Trough observed concentration (Ctrough) of subcutaneous Nivolumab
measured At Cycle 7 Day 1 (Week 18)
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