計劃書編號CA244-0010
試驗執行中
2025-10-01 - 2028-12-31
Phase II/III
召募中6
ICD-10C34.90
未明示側性支氣管或肺惡性腫瘤
ICD-10C34.91
右側支氣管或肺惡性腫瘤
ICD-10C34.92
左側支氣管或肺惡性腫瘤
ICD-10C7A.090
支氣管及肺惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9162.9
支氣管及肺惡性腫瘤
IZABRIGHT-Lung01：比較Izalontamab Brengitecan (BMS-986507)與含鉑化療用於EGFR突變且在接受EGFR酪胺酸激酶抑制劑治療後出現疾病惡化之非小細胞肺癌病患的隨機分配、開放性、第2/3期試驗
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試驗申請者
台灣必治妥施貴寶股份有限公司
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試驗委託 / 贊助單位名稱
台灣必治妥施貴寶股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
適應症
•RP3D將根據整體的安全性、耐受性、療效及藥物動力學(PK)/藥效學資料予以確定•BICR根據RECIST v1.1評估之PFS
試驗目的
第二期主要目的：
•旨在確定進入本試驗第2階段(第3期)的iza-bren第3期建議劑量(RP3D)
第三期主要目的：
•針對接受任一種第三代TKI治療後出現疾病惡化之晚期EGFRmt NSCLC參與者，比較於RP3D下使用iza-bren與PBC之PFS
藥品名稱
注射用凍晶粉末
主成份
BMS-986507
劑型
048
劑量
120 mg/Vial
評估指標
•RP3D將根據整體的安全性、耐受性、療效及藥物動力學(PK)/藥效學資料予以確定
•BICR根據RECIST v1.1評估之PFS
•BICR根據RECIST v1.1評估之PFS
主要納入條件
•經組織學或細胞學確認診斷為非鱗狀NSCLC，且不適合接受治癒性治療。
•在疾病診斷時或之後、且在開始使用EGFR-TKI之前，經當地檢測的紀錄證明確認存在EGFR第19號外顯子(ex19del)的EGFR TKI敏感性缺失突變，或EGFR第21號外顯子(ex21L858R)的白胺酸-精胺酸替換點突變。
•在輔助性、局部晚期或轉移性治療情境中，使用第三代EGFR-TKI (例如osimertinib、furmonertinib、lazertinib、aumolertinib等)為基礎的單一或合併療法作為最近一線治療後，出現疾病惡化。
•符合接受含鉑方案(cisplatin或carboplatin其中一種)併用pemetrexed治療的資格。
•在疾病診斷時或之後、且在開始使用EGFR-TKI之前，經當地檢測的紀錄證明確認存在EGFR第19號外顯子(ex19del)的EGFR TKI敏感性缺失突變，或EGFR第21號外顯子(ex21L858R)的白胺酸-精胺酸替換點突變。
•在輔助性、局部晚期或轉移性治療情境中，使用第三代EGFR-TKI (例如osimertinib、furmonertinib、lazertinib、aumolertinib等)為基礎的單一或合併療法作為最近一線治療後，出現疾病惡化。
•符合接受含鉑方案(cisplatin或carboplatin其中一種)併用pemetrexed治療的資格。
主要排除條件
1) Mixed SCLC and NSCLC histology.
2) Any evidence or suspicion of SCLC transformation (Note: Exclusion of SCLC transformation
by tumor biopsy at screening is not mandated).
3) Participants with untreated CNS metastases.
Note: Participants can enroll if CNS metastases have been definitively treated, are stable, do
not require immediate re-treatment, and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment).
Note: Participants must have discontinued corticosteroids or be on a stable/decreasing dose
of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks before starting treatment.
Note: Baseline imaging required at screening must be performed 28 days after treatment for
CNS metastases is completed. Imaging must demonstrate stable CNS metastases.
4) Leptomeningeal metastases or spinal cord compression.
5) Previously documented EGFR exon 20 insertion mutations as primary EGFR mutation.
6) Participants treated with platinum+pemetrexed+osimertinib as first-line therapy for advanced
disease and having disease progression on osimertinib monotherapy with a platinum- and
pemetrexed-free interval of ≤ 12 months.
7) Concurrent malignancy (present during screening) requiring treatment or history of prior
malignancy active within 2 years prior to treatment assignment (ie, participants with a history
of prior malignancy are eligible if treatment was completed at least 2 years before treatment
assignment and the participant has no evidence of disease). Participants with history of prior
early-stage cancer including basal/squamous cell skin cancer or non-invasive or in situ cancers
that have undergone definitive treatment at any time are also eligible if the condition would
not confound study results.
2) Any evidence or suspicion of SCLC transformation (Note: Exclusion of SCLC transformation
by tumor biopsy at screening is not mandated).
3) Participants with untreated CNS metastases.
Note: Participants can enroll if CNS metastases have been definitively treated, are stable, do
not require immediate re-treatment, and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment).
Note: Participants must have discontinued corticosteroids or be on a stable/decreasing dose
of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks before starting treatment.
Note: Baseline imaging required at screening must be performed 28 days after treatment for
CNS metastases is completed. Imaging must demonstrate stable CNS metastases.
4) Leptomeningeal metastases or spinal cord compression.
5) Previously documented EGFR exon 20 insertion mutations as primary EGFR mutation.
6) Participants treated with platinum+pemetrexed+osimertinib as first-line therapy for advanced
disease and having disease progression on osimertinib monotherapy with a platinum- and
pemetrexed-free interval of ≤ 12 months.
7) Concurrent malignancy (present during screening) requiring treatment or history of prior
malignancy active within 2 years prior to treatment assignment (ie, participants with a history
of prior malignancy are eligible if treatment was completed at least 2 years before treatment
assignment and the participant has no evidence of disease). Participants with history of prior
early-stage cancer including basal/squamous cell skin cancer or non-invasive or in situ cancers
that have undergone definitive treatment at any time are also eligible if the condition would
not confound study results.
試驗計畫預計收納受試者人數
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台灣人數
37 人
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全球人數
917 人
