Skip to content

A Phase 1/2 Randomized Trial of BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive-Stage Small Cell Lung Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511824-15-00
Acronym
CA001-044
Enrollment
1
Registered
2024-05-06
Start date
2016-10-18
Completion date
2024-08-06
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive-Stage Small Cell Lung Cancer

Brief summary

Number of participants with adverse events (AEs), Number of participants with serious adverse events (SAEs), Discontinuations due to AEs, Number of participants who died due to AEs, Number of participants with laboratory toxicity grade shift from baseline, Progression Free Survival

Detailed description

Maximum observed serum concentration(Cmax), Time of maximum observed serum concentration(Tmax), Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)), Observed serum concentration at the end of a dosing interval(Ctau), Area under the concentration-time curve in 1 dosing interval(AUC(TAU)), Characterization of Immunogenicity

Interventions

None listed

Sponsors

Bristol Myers Squibb International Corporation
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of participants with adverse events (AEs), Number of participants with serious adverse events (SAEs), Discontinuations due to AEs, Number of participants who died due to AEs, Number of participants with laboratory toxicity grade shift from baseline, Progression Free Survival

Secondary

MeasureTime frame
Maximum observed serum concentration(Cmax), Time of maximum observed serum concentration(Tmax), Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)), Observed serum concentration at the end of a dosing interval(Ctau), Area under the concentration-time curve in 1 dosing interval(AUC(TAU)), Characterization of Immunogenicity

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026