Ociperlimab
Drug900 mg intravenously (IV) once every 3 weeks (Q3W)
Other names: BGB-A1217
NCT Number: NCT05014815
This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Border Medical Oncology, East Albury, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
900 mg intravenously (IV) once every 3 weeks (Q3W)
Other names: BGB-A1217
200 mg IV Q3W
Other names: BGB-A317
Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle
75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle
100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle
75 mg/m², administered intravenously on Day 1 of each 21-day cycle
500 mg/m² administered intravenously on Day 1 of each 21-day cycle
Administered intravenously Q3W to match ociperlimab
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments.
CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.
Time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
Time frame: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)
The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.
BeiGene
Industry
AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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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