neoplasms in the lung small cell lung cancer
Conditions
Interventions
The medicinal intervention includes BMS-986012 therapy. Study drug will be
supplied by the sponsor.
Part 2 will evaluate toxicity and preliminary efficacy of BMS-986012 as
second-line monotherapy i
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed Written Informed Consent - Men and women at least 18 years of age with histological or cytological confirmed pulmonary SCLC - Have relapsed after or are refractory to first line therapy and have not yet received two or more lines of anticancer treatment - Last exposure to anticancer therapy within 4 weeks or 5 half-lives (whichever is longer) prior to study drug administration - At least one measurable lesion per RECIST v1.1 - Adequate organ function - Comply with visit and treatment schedule, sample collection for laboratory tests, and treatment and follow-up
Exclusion criteria
Exclusion criteria: - Known or suspected brain metastasis - Non-pulmonary small cell cancer - Acute or chronic medical illness - Uncontrolled or significant cardiac disease - Infection requiring systemic treatment - Grade 2 or higher peripheral neuropathy - Other concomitant malignancies (except unless complete remission was achieved 3 yrs prior to study entry) - HIV-related disease, HIV+, HepB, HepC - Allergies or adverse drug reaction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this phase 1/2 study is safety as measured by the rate of adverse events (AEs), serious adverse events (SAEs), discontinuations due to AEs, deaths, and clinically significant laboratory abnormalities. Safety will be evaluated once a subject signs informed consent through Clinical Follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: The objective response rate (ORR), duration of response, and progression free survival (PFS) will be assessed based on RECIST v1.1 criteria. In addition, PFS rates at pre-specified time points, e.g. 24, 36 weeks will be assessed. Individual best overall response (BOR) will be a subject level endpoint. The above will be determined based on tumor measurements occurring every 6 weeks during the Treatment Period, and at approximiately the 100-day Clinical Follow-up visit, according to institutional practice. Subjects not progressing at discontinuation of study treatment will undergo tumor assessments every 3-4 months or as per institutional practice until the date of the first objective documentation of tumor progression or death due to any cause. Pharmacokinetics: Cmax, Tmax, Ctau, AUC(0-T), AUC(TAU) Immunogenicity: Occurrence of specific anti-drug antibodies (ADA) to BMS-986012. Samples will be collected at multiple time points. Exploratory Biomarkers: Shed fuc-GM1, fuc-GM1 positive CTCs, NK and monocyte/macrophage counts, NK immunophenotyping, complement levels and Fc*R polymorphisms. If available, fuc-GM1 IHC of fresh biopsies and evaluation of fuc-GM1 related biomarkers of archived FFPE biopsies. | — |
Countries
Netherlands
Outcome results
None listed