Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer
An Open-label, Single-arm, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer
NCT06799286CI-TRIAL-00111348completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986489 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-986489
- interventionNames
- Drug: BMS-986489
Primary outcomes (15)
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Up to 19 months after last participant's first treatment
- measure
- Number of participants with Serious AEs (SAEs)
- timeFrame
- Up to 19 months after last participant's first treatment
- measure
- Number of participants with AEs leading to discontinuation of study treatment
- timeFrame
- Up to 19 months after last participant's first treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible. i) For initial limited stage (LS) SCLC:. A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible. ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators. A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy. * Participants must have a life expectancy of ≥12 weeks. * Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Exclusion Criteria: * Untreated symptomatic CNS metastases. * Leptomeningeal disease. * Pleural effusion which cannot be controlled with appropriate interventions. * Malignancy-related superior vena cava syndrome. * Participants with an active, known or suspected, autoimmune disease. * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment. * Unresolved toxicity from prior anti-tumor therapy. * Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1. * Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.