BMS-986489
DrugSpecified dose on specified days
NCT Number: NCT06799286
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Local Institution - 0004, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Specified dose on specified days
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
Time frame: Up to 19 months after last participant's first treatment
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.
Time frame: Up to 19 months after last participant's first treatment
Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator.
Time frame: Up to 19 months after last participant's first treatment
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.
Bristol-Myers Squibb
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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