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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986489 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986489 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 19 months after last participant's first treatment | |
| Number of participants with Serious AEs (SAEs) | Up to 19 months after last participant's first treatment | |
| Number of participants with AEs leading to discontinuation of study treatment | Up to 19 months after last participant's first treatment | |
| Number of participants with select AEs | Up to 19 months after last participant's first treatment | |
| Number of participants with immune-mediated AEs (IMAEs) | Up to 19 months after last participant's first treatment | |
| Number of deaths | Up to 19 months after last participant's first treatment | |
| Number of participants with laboratory abnormalities | Up to 19 months after last participant's first treatment | |
| Maximum observed concentration (Cmax) for BMS-986012 | Up to 19 months after last participant's first treatment | |
| Time of maximum observed concentration (Tmax) for BMS-986012 | Up to 19 months after last participant's first treatment | |
| Trough observed plasma concentration (Ctrough) for BMS-986012 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with anti-drug antibodies (ADAs) to BMS-986012 | Up to 19 months after last participant's first treatment | |
| Number of participants with ADAs to nivolumab | Up to 19 months after last participant's first treatment |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0004 | Beijing | Beijing Municipality | 100142 | China | ||
| Local Institution - 0003 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Up to 19 months after last participant's first treatment |
| Concentration at the end of a dosing interval (Ctau) for BMS-986012 | Up to 19 months after last participant's first treatment |
| Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012 | Up to 19 months after last participant's first treatment |
| Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012 | Up to 19 months after last participant's first treatment |
| Total body clearance (CLT) for BMS-986012 | Up to 19 months after last participant's first treatment |
| Observed concentration at end of infusion (Ceoi) for BMS-986012 | Up to 19 months after last participant's first treatment |
| Ctrough for nivolumab | Up to 19 months after last participant's first treatment |
| Ceoi for nivolumab | Up to 19 months after last participant's first treatment |
| Overall Response (OR) | Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. | Up to 19 months after last participant's first treatment |
| Disease Control (DC) | Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. | Up to 19 months after last participant's first treatment |
| Duration of Response (DOR) | Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. | Up to 19 months after last participant's first treatment |
| Jinan |
| Shandong |
| 250117 |
| China |
| Local Institution - 0001 | Linyi | Shandong | 276001 | China |
| Local Institution - 0005 | Hangzhou | Zhejiang | 310016 | China |
| Local Institution - 0002 | Shanghai | 200120 | China |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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