2022-04-15 - 2029-10-31
Phase II/III
召募中8
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
針對帶有 KRAS G12C 突變之晚期非小細胞肺癌患者的一項Adagrasib 單藥療法與合併 Pembrolizumab 之第 2 期試驗，以及一項 Adagrasib 合併 Pembrolizumab 相對於 Pembrolizumab 之第 3 期試驗
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
保瑞爾生技股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/04/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
試驗目的
藥品名稱
注射劑
主成份
Pembrolizumab
劑型
Tablet
Concentrate for solution for infusion
Concentrate for solution for infusion
劑量
25mg/mL
評估指標
•依據實體腫瘤反應評估標準第 1.1 版 (RECIST 1.1) 定義的客觀反應率 (ORR)
第 3 期
•由盲性獨立中央審查 (BICR) 依據 RECIST 1.1 評估的無惡化存活期和整體存活期
主要納入條件
INCLUSION CRITERIA
1. Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
EXCLUSION CRITERIA
1. Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
2. Active brain metastases.
Phase 3
INCLUSION CRITERIA
1. Histologically confirmed diagnosis of unresectable or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS <50%
2. Presence of evaluable or measurable disease per RECIST
3. CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
(a) No evidence of brain metastases
(b) Untreated brain metastases not needing immediate local therapy
(c) Previously treated brain metastases not needing immediate local therapy
PRINCIPAL EXCLUSION CRITERIA
1. Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (eg, AMG 510).
2. Patients with known central nervous system (CNS) lesions must not have any of the following:
(a) Any untreated brain lesions > 1.0 cm in size
(b) Any brainstem lesions
(c) Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization.
(d) Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
3. Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment
試驗計畫預計收納受試者人數
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台灣人數
11 (Phase 2) + 23 (Phase 3) 人
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全球人數
240 (Phase 2) + 770 (Phase 3) 人
