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Study of BMS-986012 in Subjects With Small Cell Lung Caner

A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223369
Enrollment
18
Registered
2016-11-08
Start date
2016-11-08
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : BMS-986012, Cisplatin, Etoposide INN of investigational material : Cisplatin, Etoposide Therapeutic category code : 42- Antineoplastic agents Dosage and

Sponsors

Bristol-Myers Squibb K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological or cytological confirmed small cell lung cancer (SCLC) Eastern Cooperative Oncology Group Performance Status 0-1 at least one measurable lesion that is not amenable to resection. Adequate organ function

Exclusion criteria

Exclusion criteria: Symptomatic central nervous system (CNS) metastases Greater than or equal to Grade 2 peripheral neuropathy Uncontrolled or significant cardiac disease Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)

Design outcomes

Primary

MeasureTime frame
Safety and Tolerability Number of participants with adverse events (AEs) Number of participants with serious adverse events (SAEs ) Number of Discontinuations due to AEs Number of Deaths due to AEs Number of participants with laboratory toxicity grade shift from baseline

Secondary

MeasureTime frame
Pharmacokinetics (PK) Immunogenicity Efficacy Following PK Parameters: Cmax, Tmax, AUC(0-T), Ctau, AUC(TAU) Anti-drug antibodies (ADA) Best overall response (BOR) and duration of response (DOR)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026