预约演示
更新于：2026-10-28
Retifanlimab
瑞弗利单抗
更新于：2026-10-28
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2023-03-22), |
最高研发阶段(中国)临床3期 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (美国) |
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结构/序列
Sequence Code 12981416H
来源: *****
Sequence Code 13030670L
来源: *****
关联
70
项与 瑞弗利单抗 相关的临床试验NCT07765836
A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)
This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).
开始日期2027-01-01 |
申办/合作机构 |
NCT07772245
Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer
The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate [residual cancer burden (RCB)- 0] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.
开始日期2026-12-31 |
NCT07472322
UW26001 Phase I/II Study on the Safety, Tolerability, and Preliminary Efficacy of ASTX727 (Decitabine/Cedazuridine) and Retifanlimab-dlwr in Patients With Advanced Merkel Cell Carcinoma Who Have Progressed on Anti-PD-(L)1 Inhibitor
The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are:
* Can the combination shrink cancer and lower the chance of the cancer growing or spreading?
* Is the combination better than standard of care for Merkel cell cancer?
Participants will:
* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years.
* Visit the clinic once every 2 weeks for checkups and tests
* Can the combination shrink cancer and lower the chance of the cancer growing or spreading?
* Is the combination better than standard of care for Merkel cell cancer?
Participants will:
* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years.
* Visit the clinic once every 2 weeks for checkups and tests
开始日期2026-10-01 |
100 项与 瑞弗利单抗 相关的临床结果
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100 项与 瑞弗利单抗 相关的转化医学
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100 项与 瑞弗利单抗 相关的专利（医药）
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31
项与 瑞弗利单抗 相关的文献（医药）2026-10-15·CLINICAL CANCER RESEARCH
Article
作者: de Claro, R. Angelo ; Tang, Shenghui ; Saung, May Tun ; Lemery, Steven J. ; Casak, Sandra J. ; Mishra-Kalyani, Pallavi S. ; Auth, Doris ; Gandhy, Shruti U.
2026-10-01·Dermatologie (Heidelberg, Germany)
Update anale Dysplasien und Analkarzinom
Review
作者: Wieland, Ulrike ; Chromy, David ; Kreuter, Alexander
2026-08-01·ANNALS OF ONCOLOGY
Article
作者: Roy, A ; Lievre, A ; Maurel, J ; Dahan, L ; Rao, S ; Guimbaud, R ; Zhang, P ; Fakih, M ; Zampino, M G ; Samalin-Scalzi, E ; Evesque, L ; Munteanu, M C ; Dhadda, A S ; Takashima, A ; Spano, J ; Casanova, N ; Tamberi, S ; Morano, F ; de la Fouchardiere, C ; Ben Abdelghani, M ; Jones, M
266
项与 瑞弗利单抗 相关的新闻（医药）2026-10-23
Dynamic changes in PD-L1 expression on circulating cancer-associated macrophage-like cells (CAML) were significantly associated with progression-free survival and overall survival following immunotherapies including the BriaCell regimen
Findings from a prospective pooled analysis of 111 heavily pretreated metastatic breast cancer patients support further evaluation of circulating CAML PD-L1 as a potential biomarker of clinical benefit from immunotherapies
Pooled analysis includes patients from multiple studies, including BriaCell’s earlier Phase 1/2 Bria-IMT™ study
PHILADELPHIA and VANCOUVER, British Columbia, Oct. 23, 2026
(GLOBE NEWSWIRE)
-- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced the presentation of clinical biomarker findings from a prospective pooled analysis of patients with metastatic breast cancer (“MBC”) treated with immune based therapies including the BriaCell regimen at the European Society for Medical Oncology (“ESMO”) Congress 2026, taking place October 23-27, 2026 in Madrid, Spain. The data shown is pooled from several studies including BriaCell’s Phase 1/2 Bria-IMT study.
The analysis evaluated changes in programmed death-ligand 1 (“PD-L1”) expression on circulating cancer-associated macrophage-like cells (“CAMLs”) before and after initiation of immunotherapy and their association with progression-free survival (“PFS”) and overall survival (“OS”). The findings suggest that changes in CAML PD-L1 following treatment may provide information regarding clinical outcomes that are not captured by a single pretreatment measurement.
“We are encouraged by these findings showing that dynamic changes in a circulating immune biomarker were associated with progression-free and overall survival in patients with metastatic breast cancer treated with immunotherapies,” stated Dr. William V. Williams, BriaCell’s President and CEO. “These results support further study of CAML PD-L1 as a potential tool for understanding treatment response and identifying patients most likely to benefit from immunotherapy, including the Bria-IMT regimen.”
Poster #4506 -
Monitoring Circulating Cancer Associated Macrophage-like Cell PD-L1 Predicts Clinical Outcomes in Metastatic Breast Cancer Treated with Immune Checkpoint Inhibitors
The prospective, multi-institutional pooled analysis included 111 patients with MBC who had received at least one prior line of therapy and were treated with pembrolizumab, retifanlimab, atezolizumab, or nivolumab. Some also received combination therapy with the Bria-IMT regimen. Patients had a median age of 59 years, with a range of 32 to 77 years, and had received a median of two prior metastatic lines of therapy, with a range of one to 13.
Among the 111 patients, 39% were estrogen receptor-positive, 31% were progesterone receptor-positive, 5% were HER2-positive, and 60% had triple-negative breast cancer.
Peripheral blood samples were collected prior to initiation of immunotherapy, approximately 37 days after initiation of immunotherapy (“T1”), and approximately three months after initiation of immunotherapy (“T2”). CAMLs were isolated from blood samples, and PD-L1 expression was categorized as low or high.
Key findings included:
At baseline, CAML PD-L1 was not significantly associated with either PFS or OS.
At T1, approximately 37 days following initiation of immunotherapy, CAML PD-L1 was significantly associated with PFS (HR=1.86; p=0.0276), but not OS (HR=1.28; p=0.5663).
At T2, approximately three months following initiation of immunotherapy, CAML PD-L1 was significantly associated with both PFS (HR=2.73; p=0.0028) and OS (HR=2.27; p=0.0420).
Pretreatment tumor PD-L1 combined positive score (“CPS”) of 10 or greater was not significantly associated with improved PFS or OS in the pooled population.
“These findings suggest that monitoring dynamic PD-L1 changes in circulating tumor-associated immune cells following initiation of immunotherapy may provide information regarding clinical benefit in patients with MBC and are consistent with findings reported in the Bria-IMT Phase 2 study,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “Further studies are needed to validate CAML PD-L1 as a predictive biomarker.”
About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients
BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.
The study’s primary endpoint is overall survival, comparing patients treated with the Bria-IMT combination regimen with patients receiving physician’s choice treatment. The planned interim analysis will be conducted following 144 patient deaths. Positive results from the pivotal Phase 3 study could support a potential application for marketing approval of Bria-IMT in metastatic breast cancer.
BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen
. The Bria-IMT combination regimen has received FDA Fast Track designation.
For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov
NCT06072612
.
A copy of the poster presentation is available at
.
About BriaCell Therapeutics Corp.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at
.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the presentation of clinical data at the ESMO Congress 2026, and the contents of all such presentations, the early constructive clinical biomarker data allowing the Company to predict clinical and survival outcomes and guide treatment decisions for metastatic breast cancer patients, and the Company’s anticipated timing of analysis of interim data, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at
and on EDGAR at
. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Investor Relations Contact:
investors@briacell.com
临床结果免疫疗法临床3期快速通道
2026-10-17
·医药速览
分享一篇新的关于B7H3靶点的综述。
免疫检查点蛋白 B7-H3（CD276）作为癌症免疫治疗靶点日益受到关注。尽管尚未明确鉴定出其受体，但 B7-H3 被认为参与了肿瘤进展的多种机制。作为一种癌症生物标志物，它在多种癌症类型中过表达，且常与不良预后相关。B7-H3 目前是众多免疫治疗策略的靶点，相关临床试验正在多种癌症类型中开展。
主要内容
免疫治疗，无论是单独使用还是与放疗、化疗等传统疗法联合使用，都代表着癌症治疗领域的一种变革性方法。在各类免疫治疗策略中，靶向免疫检查点蛋白（ICPs）已在临床上展现出显著的成效。值得关注的抑制性检查点，包括程序性细胞死亡蛋白1（PD-1）和细胞毒性T淋巴细胞相关蛋白4（CTLA-4），是免疫激活的关键调节因子，但肿瘤细胞常常通过改变其表达来利用它们逃避免疫监视。免疫检查点抑制剂（ICIs）对免疫抑制性ICPs的抑制可对抗这种抑制，恢复抗肿瘤免疫，并在多种恶性肿瘤中产生持久的临床反应。在已获批的免疫疗法中，ICIs仍然是最具前景的一类，其中已有数款获得了美国食品药品监督管理局（FDA）的批准。
尽管在监管层面取得了显著成功，ICIs仍面临重大挑战，包括耐药性、疗效有限、缺乏可靠的ICI应答预测因子、获益不持久以及毒性。因此，为提高应答率并识别新治疗靶点而持续开展的努力，已将B7家族的成员B7-H3凸显为免疫检查点抑制的一个有前景的候选靶点。
B7 家族
B7 家族由结构相关的免疫调节蛋白组成，它们向免疫细胞提供共刺激或共抑制信号，在初始淋巴细胞的双信号模型中充当“第二信号”。在抗原提呈细胞（APCs）与 T 细胞之间发生初始的主要组织相容性复合体-T 细胞受体（MHC-TCR）信号之后，这些“第二信号”免疫调节蛋白通过与其各自的受体结合，调节淋巴细胞的刺激、抑制或应答调谐，从而调控淋巴细胞活化以决定最终的免疫应答。根据具体情境，B7 家族成员既可增强也可抑制免疫应答，从而维持免疫稳态。B7 家族是一种关键的次级信号机制，对于维持免疫效能与抑制自身免疫之间的平衡至关重要。尽管序列同源性较低，B7 家族成员仍共享保守的结构域结构。常见的几个B7家族的包括B7H5(VISTA)、B7H3(CD276)、B7-H1(CD274，PDL1)等
B7-H3 与其他 B7 家族成员的氨基酸同源性为 20-27%，同时具有高度多样化的胞质尾结构域，以及 B7 家族成员特征性的免疫球蛋白恒定区和可变区（IgC 和 IgV）样结构域，提示 B7-H3 在初始致敏阶段之后对 T 细胞和自然杀伤（NK）细胞应答的调节中发挥作用。
1、B7-H3 的结构与异构体
B7-H3 最初被鉴定为一种含有316个氨基酸的 I 型跨膜蛋白，具有单个胞外 IgV 和 IgC 结构域、一个跨膜区以及一个 45 个氨基酸的胞质尾（高度多样化的胞质结构域）。在人类中，B7-H3 存在两种异构体：2IgB7-H3 和4IgB7-H3，4IgB7-H3由结构域重复产生，是大多数正常组织和肿瘤细胞系中的主要形式，但脑和胎盘除外。然而，近期证据提示，2IgB7-H3 在某些肿瘤类型中也可能存在差异表达并具有功能相关性，凸显了两种异构体潜在的生物学意义。
4IgB7-H3 重复的 IgC-IgV 结构域可能使其能够同时连接两个受体。尽管人与小鼠的 B7-H3 具有高度的序列同源性，但小鼠 B7-H3 仅表达为 2Ig 异构体，由 9a 号染色体编码，而人 B7-H3 位于 15 号染色体。
除跨膜形式外，B7-H3 还存在一种可溶性异构体（sB7-H3），已在健康个体的血清中检测到。sB7-H3 由免疫细胞和肿瘤细胞释放，包括树突状细胞、单核细胞、活化 T 细胞和癌细胞，并保持功能活性，保留与 T 细胞上尚未鉴定的受体结合的能力。已有报道显示，多种恶性肿瘤中 sB7-H3 水平升高，包括胃腺癌、肝细胞癌、骨肉瘤和非肌层浸润性膀胱癌。sB7-H3 表达升高与不良临床病理特征相关，如晚期肿瘤分期、侵袭、转移和较差的临床结局。除预后价值外，sB7-H3 还可能通过充当诱饵靶点而使治疗开发复杂化，可能降低针对膜结合型 B7-H3 的疗法的疗效并增加脱靶效应。这些发现凸显了对 B7-H3 异构体进行疾病特异性表征以及开发异构体选择性治疗策略的重要性。
2、候选B7-H3受体的总结
尽管研究广泛，B7-H3 的确切受体至今仍未确定。TLT-2、IL-20RA、PLA2R1、AAMP 等都是候选，但多数存在争议或未被完全验证。这也是该领域机制研究和药物优化的重大障碍。
3、B7-H3的免疫相互作用
4、B7-H3在癌症促进中的作用
5、Jak2/Stat3信号通路
6、可能的表达调控因子
7、针对B7-H3的抗体疗法
包括CART、CAR-NK、ADCC增强型单抗、双特异性抗体、ADC等；
抗体偶联药物（ADC）是目前最成熟的赛道：
第一三共I-DXd (DS-7300a)：临床进度靠前，SCLC 中 ORR 约 52%，曾获 FDA 突破性疗法认定。
翰森制药HS-20093：早期数据中 SCLC 亚组缓解率高达 77.8%。
宜联生物YL201 (Tam-Peli)：ES-SCLC 的 ORR 为 63.9%，DCR 83.6%。
其他如MGC018、ABBV-155、7MW3711 等也在早期临床中显示出不同程度活性，但血液学毒性（中性粒细胞减少、血小板减少）是该类药物的共性挑战。
8、靶向B7-H3的临床试验及其结果
试验注册号及分期
药物/治疗方案
治疗类型
癌症类型
结果NCT01391143 (I)
MGA271 (Enoblituzumab)
诱导 ADCC 的单克隆抗体
难治性癌症（多种类型）
MGA271 耐受性良好。在多种肿瘤类型中观察到疾病稳定和肿瘤缩小 。NCT02923180 (II)
MGA271 (Enoblituzumab)
诱导 ADCC 的单克隆抗体
前列腺癌
治疗耐受性良好。可能改善了临床结局。治疗与净分级组降低之间存在关联。TME（肿瘤微环境）分析提示存在炎症性抗肿瘤反应 。NCT02475213 (I)
MGA271 (Enoblituzumab) + 帕博利珠单抗/MGA012
B7-H3 ADCC 诱导单抗 + 抗 PD-1 单抗
黑色素瘤、头颈癌、非小细胞肺癌、尿路上皮癌
≥3 级治疗相关不良事件发生率为 28.6%。在约三分之一的抗 PD-1/PD-L1 初治患者（头颈部鳞状细胞癌和非小细胞肺癌）中观察到客观缓解 。NCT04634825 (II)
Enoblituzumab + Retifanlimab (MGA012) 或 Tebotelimab (MGD013)
B7-H3 ADCC 诱导单抗 + PD-1 单抗(MGA012) 或 PD-1 × LAG-3 双特异性 DART (MGD013)
头颈癌、头颈部肿瘤、头颈部鳞状细胞癌
在 MGA271 联合 MGA012 的 48 例患者队列中，6.3% (3/48) 达到 PR，41.7% (20/48) 达到至少 3 个月的 SD。在 MGA271 联合 MGD013 的 14 例患者队列中，14.3% (2/14) 达到 PR，35.7% (5/14) 达到至少 3 个月的 SD 。NCT00089245 (I)
131I-omburtamab (131I-8H9)
放射免疫治疗
脑和中枢神经系统肿瘤、神经母细胞瘤、肉瘤
在 CNS 复发的神经母细胞瘤 (NB) 患者中，44% (7/16) 在腔内免疫治疗 13-17 年后为长期生存者，仅 13% (2/16) 在接受腔内放射免疫治疗后出现进一步的 CNS 复发，与历史数据相比显著增加 (90)。NCT03275402 (II/III)
131I-omburtamab (131I-8H9)
放射免疫治疗
神经母细胞瘤、CNS 转移、软脑膜转移
最常见的 3/4 级不良事件为骨髓抑制。估计 6 个月时的 CNS/LM PFS 为 75%；12 个月时的 OS 为 79%。ORR 为 35%（基线有可测量病灶的 7/20 例患者），CR 为 25%。DCR 为 70% (89)。NCT01099644 (I)
131I-omburtamab (131I-8H9)
放射免疫治疗
腹膜癌
无剂量限制性毒性，正常器官辐射暴露低。II 期试验已启动（ClinicalTrials.gov 注册号：NCT04022213）。NCT00582608 (N/A)
131I-omburtamab
放射免疫治疗
CNS 癌症、神经母细胞瘤、肉瘤
尽管肝脏表达水平低，但显示出肝脏摄取 (124)。80% (4/5) 的患者出现/有风险出现严重不良事件。100% (5/5) 出现/有风险出现其他非严重不良事件 。NCT01502917 (I)
124I-omburtamab
放射免疫治疗
脑癌、脑干胶质瘤、DIPG
5 例剂量限制性毒性 (5/50)。全身暴露可忽略不计。NCT04167618 (II/II)
177Lu-DTPA-omburtamab
放射免疫治疗
儿童髓母细胞瘤
接受 10 mCi 177Lu-DTPA-omburtamab 的患者 (1/1) 出现部分性癫痫发作，无其他非严重不良事件。接受 25 mCi 177Lu-DTPA-omburtamab 的患者 (1/1) 仅出现非严重不良事件 。NCT03729596 (I/II)
MGC018 (vobramitamab duocarmazine) + MGA012
抗 B7-H3 ADC (MGC018) + 抗 PD-1 单抗 (MGA012)
晚期实体瘤
剂量递增阶段在黑色素瘤患者中显示出临床活性证据（靶病灶总长减少）。在队列扩展阶段，87.7% (43/49) 的患者发生 TEAE（治疗期间出现的不良事件）。在 4/7 可评估的 mCRPC（转移性去势抵抗性前列腺癌）患者中观察到靶病灶总长减少。11/22 可评估患者的 PSA 降低至少 50%。NCT04145622 (II/II)
DS-7300a (Ifinatamab Deruxtecan 或 I-DXd)
ADC
晚期实体瘤
98% (124/127) 的患者发生 TEAE。总体可评估患者中有 33% (30/91) 观察到缓解（7/9 例 SCLC，2/5 例 sqNSCLC，16/42 例 mCRPC）。其他发现包括：CRPC 的 ORR 为 25% (15/59)，ESCC（食管鳞癌）为 21% (6/28)，sqNSCLC 为 31% (4/13)，SCLC 为 52% (11/21)，以及令人鼓舞的 DOR 和 OS。NCT05276609 (I)
HS-20093
ADC
晚期实体瘤
53/53 例患者发生 TEAE。在可评估缓解的患者中，14/40 达到 PR（9 例确认；5 例待确认）（缓解率 35%），DCR 为 85% (34/40)。SCLC 亚组的缓解率为 77.8% 。NCT03595059 (I)
ABBV-155 (Mirzotamab clezutolax 或 Mirzo-C) + 紫杉醇或多西他赛
ADC
复发和/或难治性实体瘤
安全性特征可耐受，SCLC、NSCLC 和乳腺癌队列的 ORR 分别为 0% (0/14)、11% (4/36) 和 18% (5/28) 。NCT05434234 (I) / NCT06057922 (I)
YL201，Tam-peli
ADC
晚期实体瘤
在重度经治患者中具有可接受的安全性特征和令人鼓舞的疗效。DCR 为 83.6%。令人鼓舞的 ORR 包括 ES-SCLC 的 63.9%、鼻咽癌的 48.6% 和淋巴上皮瘤样癌的 54.2%，所有患者的总体 ORR 为 40.8% 。CTR20231298 (I/II)
MHB088C
ADC
mCRPC、ES-SCLC
在重度经治的 mCRPC 中具有可接受的安全性特征和令人鼓舞的疗效（ORR 14.3%，DCR 95.2%，6 个月 rPFS 87%），并在 2.0 mg/kg 队列 (n=33) 的复发性 ES-SCLC 患者中显示出活性（确认 ORR 42.4%，中位 PFS 5.9 个月，DCR 87.9%）。NCT06008379 (I/II)
7MW3711
ADC
晚期实体瘤
在其他治疗方案后进展的 SCLC 患者 (n=8) 中，4.5 mg/kg 剂量下的 ORR 为 62.5%，DCR 为 100%。在一些 Sq-NSCLC（鳞状非小细胞肺癌）患者中也观察到令人鼓舞的结果 。NCT06008366 (I/II)
7MW3711
ADC
晚期实体瘤
在至少 4.5 mg/kg 剂量入组且可评估肿瘤的晚期食管癌、铂耐药卵巢癌和前列腺癌患者中，该 ADC 显示出令人鼓舞的结果，ORR 分别为 33.3%、60% 和 50%，三个疾病队列 (n=15) 的 DCR 均为 100% 。ChiCTR2100047968
MT027
靶向 B7-H3 的现货型同种异体 CAR-T (UCAR-T)
复发性高级别胶质瘤
耐受性和安全性可接受，出现 3 例 (6%) SAE。多次给药后，CAR-T 细胞数量保持高位，CSF 中 IL6、TNF-α 和 IFN-γ 水平升高，且升高具有持久性。在接受三次或以上给药且至少一次疗效访视的队列 (n=15) 中，ORR 为 33%，DCR 为 80% 。NCT04185038 (I)
B7-H3 CAR T 细胞 (SCRI-CARB7H3)
CAR T
CNS 肿瘤、DIPG
在前三例可评估的 DIPG 中，证明 CAR T 细胞能够在 CSF 中持续存在。趋化因子/细胞因子分析和蛋白质组学评估支持局部 CNS 免疫激活。在整个治疗过程中检测到血清 B7-H3 水平下降。初始肿瘤进展后入组的患者表现出肿瘤体积增加伴浸润，但在进展前入组的患者表现出肿瘤尺寸轻度减小，肿瘤结节显影减少，并且面神经麻痹在研究 12 个月内持续改善 。NCT04483778 (I)
B7-H3 CAR T 细胞
CAR T 细胞/多抗原靶向 CAR T 细胞联合抗 PD-1 单抗
儿童实体瘤
在接受表达 EGFR 的 B7-H3 CAR T 细胞（A 组）输注的患者中，9 例输注受试者中有 3 例观察到最佳总体缓解为 SD。在接受 B7-H3xCD19 CAR T 细胞输注的患者中，11 例输注受试者中有 2 例观察到最佳总体缓解 。
小结
B7-H3 是一个表达广、预后差、机制多面的“明星靶点”。目前 ADC 药物领跑临床转化（尤其是小细胞肺癌），但受体未明、生物标志物缺失和毒性管理仍是将其潜力转化为持久临床获益的关键瓶颈。
参考文献：Smith D, Tyagi A and Battula VL (2026) B7-H3 (CD276): an actionable therapeutic target and prognostic biomarker across human malignancies. Front. Immunol. 17:1857767. doi: 10.3389/fimmu.2026.1857767.
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2026-09-23
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读书笔记丨感恩并传承CTONG-中国肺癌原创临床研究
写意人物丨陆舜教授：从PI的角度看中国创新药的发展
陆舜教授：有的放矢，做肺癌研究领域的“领潮儿”
陆舜教授：沃利替尼有望成为首个代表中国走向全球的肺癌靶向创新药物陆舜：引领中国抗肿瘤药物研发，将肺癌变成慢性病他的愿望：让肺癌变成慢性病——访上海市胸科医院肿瘤科主任陆舜教授医语舜间丨记录陆舜教授肺癌诊疗领域30余年的精彩瞬间上海交通大学附属胸科医院陆舜教授团队肺癌国内外适应症相关研究阶段汇总推动行业前行的力量-十大医学创新专家推动行业前行的力量-十大医学新锐致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）迎难而上丨中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神胸部肿瘤 “工业革命” 成果阶段汇总丨中国胸部肿瘤临床试验转化研究长三角模式探索
江浙沪地区历届重要肺癌论坛汇总（长三角地区肺癌论坛系列）
传承与发展丨长三角肺癌代表性著作汇总传承与发展丨长三角肺癌协作组指南/专家共识汇总读书笔记丨长三角肺癌科技成果奖励阶段汇总
直播课丨长三角肺癌协作组-罕见靶点临床试验招募全国巡讲系列汇总
光荣榜丨长三角肺癌协作组陆舜教授团队历届国际会议大会发言汇总
携手共赢丨长三角肺癌与知名药企临床研究合作成果阶段汇总
长三角肺癌协作组青年博士团队组织框架介绍长三角肺癌之光丨星星之火可以燎原-基层肺癌协作组的前世今生共谋江苏省基层医院肺癌未来发展之路
齐聚浙江嘉兴，长三角肺癌再续新篇章——浙江省基层肺癌协作组成立
长三角肺癌之光丨金陵肺癌传承与发展
长三角肺癌之光丨浙江肺癌传承与发展
长三角肺癌之光丨南昌肺癌传承与发展杭州肺癌之光丨嘉兴肺癌（杭州肺癌-嘉兴支）传承与发展杭州肺癌之光丨湖州肺癌（杭州肺癌-湖州支）传承与发展杭州肺癌之光丨台州肺癌（杭州肺癌-台州支）传承与发展光荣榜丨长三角肺癌-国科大支（杭州肺癌）国际会议大会发言汇总历史回顾丨浙江省肿瘤医院胸部肿瘤青年医师精彩亮相2016WCLC浙江省肿瘤医院胸部肿瘤内科临床试验汇总长三角实体瘤病友交流群系列全面上线
● 中国原创肺癌 ●
●●●Original lung cancer of China●●●
N Engl J Med（3篇），Lancet（3篇），JAMA（1篇），Lancet Oncol（5篇），Lancet Respir Med（7篇），J Clin Oncol（3篇），JAMA Oncol（1篇），Nat Med（2篇），Cancer Cell（1篇），Cancer Discov（1篇），Ann Oncol（2篇），J Thorac Oncol（15篇），Clin Cancer Res（2篇）
中国原创肺癌
时代背景
赶潮儿（1999-2009）
1999年，中国国家食品药品监督管理总局（CFDA）成立，中国自此有了真正药物临床试验质量管理规范GCP指导原则。那时，我国肺癌学者紧跟国外潮流，按国际的临床标准做临床试验。大多临床研究都由国外学者设计方案，当时的中国只能照本宣科。在这10年当中我们和外国人学习临床试验怎么做，临床试验方案是外国学者定的，我们只是执行，只是在贡献患者，没有话语权。
弄潮儿（2009-2019）
2009年，振奋人心的IPASS研究发表，这是中国肺癌学者的姓名首次登上了权威N Engl J Med。届时，我国在自身基础上参与国际大型研究设计。在肺癌领域的临床试验中，中国很多学者开始担任研究的领头人和研究委员会成员，我们参加了方案的讨论，最终的试验方案也根据我们的意见做了一些修订，包括对照组的化疗剂量等方面。虽然我们很少有机会做领头人，但是我们有话语权，可以对试验方案提出我们的意见。
领潮儿（2019- ）
在越来越多的研究中我们开始担任领头人。这有两个原因：一是得益于前20年我们临床医生对临床研究的理解积累、贡献和影响；第二个也是得益于中国创新药企业的发展，中国药厂做的药，临床研究中肯定会有中国人做领头人。
中国胸部肿瘤临床试验转化研究长三角模式探索（2019-2059）四部曲。致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神
重要历史事件——CTONG成立（2007）成立于赶潮儿阶段末期，发展于弄潮儿阶段并达到高潮。读书笔记丨感恩并传承CTONG-中国肺癌原创临床研究
中国胸部肿瘤协作组（CTONG）启动会：2007年第十届全国肺癌大会
踏歌而行-中国胸部肿瘤研究协作组十年发展历程（2007-2017）发布会：2017年第七届中国肿瘤学临床试验发展论坛
CTONG YOUNG成立：2023年第十三届中国肿瘤学临床试验发展论坛
重要历史事件——ECLUNG成立（2019）成立于领潮儿阶段初期。
长三角肺癌协作组（ECLUNG）启动会：2019年第八届西湖肺癌论坛
迎难而上-长三角肺癌十年发展史（2019-2029）
砥砺前行-长三角肺癌二十年发展史（2019-2039）
踏歌而行-长三角肺癌三十年发展史（2019-2049）
传承发展-长三角肺癌四十年发展史（2019-2059）
ECLUNG YOUNG成立：2021年首届长三角肺癌博士研究论坛
我们的事业：中国胸部肿瘤临床试验转化研究长三角模式探索
中国胸部肿瘤临床试验转化研究长三角模式探索
长三角肺癌临床试验方面有着非常深厚的历史文化底蕴，回顾历史我们发现中国临床肿瘤领域三大前辈（孙燕，廖美琳，管忠震）中，廖美琳教授是唯一一位专注肺癌的资深大咖，1970年在国内成立首个肺癌化疗专业病房，2004年作为主要研究者代表中国大陆肺癌学界参与首项国际多中心临床研究（INTEREST研究），2003年开始举办首届上海国际肺癌论坛，2012年开始举办首届中瑞国际肺癌论坛，并持续至今，影响力深远。陆舜教授在肺癌临床试验方面有着非常丰富的经验，中国首个、世界第二的肺癌第三代EGFR靶向药物阿美替尼获批上市，这是中国自主研发的第三代EGFR靶向药，打破了晚期肺癌治疗耐药后只能依赖一种进口药的困境；中国自主研发的创新1.1类新药赛沃替尼获中国国家药品监督管理局批准上市，可用于治疗MET14号外显子跳跃突变阳性的晚期非小细胞肺癌（NSCLC）患者，作为在全球范围内的首次获批，赛沃替尼不仅填补了中国此类靶向药的空白，还有望成为首个代表中国走向世界的肺癌靶向创新药物；吡咯替尼是首个由中国自主研发的新一代HER2受体抑制剂，在临床研究中疗效远超同类产品。陆舜教授和宋正波教授领衔的吡咯替尼临床研究在国际上首次证实HER2扩增晚期非小细胞肺癌（NSCLC）患者疗效显著，为扩展吡咯替尼在HER2扩增晚期非小细胞肺癌（NSCLC）的适应症做出了历史性贡献，基于以上重大成果陆舜教授荣获2021年第十五届“药明康德生命化学研究奖”。
为了响应“长三角一体化发展规划”，推动肺癌规范化诊治及创新研究，2019年12月底，由上海交通大学附属胸科医院、东部战区总医院、中国科学院大学附属肿瘤医院、浙江大学医学院附属杭州市第一人民医院等40余家来自江、浙、沪、赣、皖地区的医疗机构，共同成立“长三角肺癌协作组”。成立协作组的目的，是通过设计、开展肺癌研究领域的多中心临床试验及转化研究，特殊病例多中心会诊等，为肺癌临床实践提供高级别的循证医学证据，促进长三角地区肺癌的诊疗、转化研究的创新性及前沿性，提高东部地区肺癌的诊治水平和国际影响力。
长三角肺癌青年博士研究团队（长三角肺癌新生代）把中国胸部肿瘤临床试验转化研究长三角模式探索作为奋斗的事业，迎难而上作为中国胸部肿瘤临床试验转化研究长三角模式探索的方向标，长三角肺癌新生代结合时代背景特征在未来四十年时间（2019-2059）选择迎难而上，勇于向各种艰难困苦挑战和亮剑。
“爬雪山”和“过草地”
长三角肺癌邀请函长三角肺癌临床试验转化研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索样本库系列研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌真实世界研究合作邀请函丨中国胸部肿瘤临床试验转化研究长三角模式探索
长三角肺癌基金系列长三角肺癌英才计划基金申请公告长三角肺癌新产品新技术研发-领航计划基金申请公告长三角肺癌新药研发-扬帆计划基金申请公告
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Lancet Reg Health West Pac（NCT04923945）Lancet Reg Health West Pac Efficacy and safety of savolitinib in Chinese patients with locally advanced or metastatic MET exon 14-mutated non-small cell lung cancer: final results of a confirmatory Phase 3b study Shun Lu（2026）
Lancet （SACHI）Lancet Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial Shun Lu（2026）
Transl Lung Cancer Res（GLORY）Transl Lung Cancer Res Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer Shun Lu, Yong-feng Yu（2025）
EClinicalMedicine（NCT03917043）EClinicalMedicine Safety, pharmacokinetic, pharmacodynamic, and efficacy properties of orally administered APG-2449 in patients with advanced ALK+ and ROS1+ non-small-cell lung cancer: a multicentre, open-label, single-arm phase 1 trial Zheng-bo Song（2025）
Clin Transl Oncol（ChiCTR2400087743）Clin Transl Oncol Intrapleural anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a prospective, single-arm, single-center, phase I trial Yong Song, Tang-feng Lv, Ping Zhan, Yue Hao（2025）
Eur J Cancer（NCT04585035 and D1553-102）Eur J Cancer Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: a pooled analysis of phase 1/2 study Shun Lu, Zheng-bo Song, Zi-ming Li, Chun-wei Xu（2025）
Cancer Cell（NCT05154604）Cancer Cell TROP-2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: a first-in-human phase 1 study Zheng-bo Song（2025）
Lancet Respir Med（POD1UM-304）Lancet Respir Med Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study Shun Lu（2025）
Lancet （HARMONi-6）Lancet Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial Shun Lu（2025）
Nat Med（NCT05410145）Nat Med D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial Shun Lu, Zheng-bo Song（2025）
N Engl J Med（MARIPOSA）N Engl J Med Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC Shun Lu（2025）
Lancet Oncol（HORIZON-Lung）Lancet Oncol Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study Shun Lu, Zi-ming Li（2025）
Signal Transduct Target Tar（NCT04878016）Signal Transduct Target Tar A multicenter, randomized, double-blind, placebo-controlled phase 3 study of socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer Shun Lu（2025）
Signal Transduct Target Tar（NCT04566432）Signal Transduct Target Tar Noninvasive early identification of durable clinical benefit from immune checkpoint inhibition: a prospective multicenter study (NCT04566432) Shun Lu（2024）
J Thorac Oncol（NCT05116007）
J Thorac Oncol Ivonescimab combined with etoposide plus carboplatin as first-line treatment for extensive-stage small-cell lung cancer: results of a phase Ib clinical trial Shun Lu（2024）
J Thorac Oncol（PEARL）
J Thorac Oncol Durvalumab versus chemotherapy as first-line treatment for metastatic NSCLC with tumor PD-L1 expression ≥25%: results from the randomized phase 3 PEARL study Shun Lu（2024）
J Clin Oncol（NCT05301517）J Clin Oncol Efficacy and safety of roxadustat for anemia in patients receiving chemotherapy for nonmyeloid malignancies: a randomized, open-label, active-controlled phase III study Shun Lu（2024）
Ann Oncol（LAURA）Ann Oncol Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study Shun Lu（2024）
Lancet Respir Med（NCT04923945）
Lancet Respir Med Savolitinib in patients in China with locally advanced or metastatic treatment-naive non-small-cell lung cancer harbouring MET exon 14 skipping mutations: results from a single-arm, multicohort, multicentre, open-label, phase 3b confirmatory study Shun Lu（2024）
Lung Cancer（IBIO-102）
Lung Cancer Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial Shun Lu（2024）
Cancer Commun（AENEAS）
Cancer Commun Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS) Shun Lu（2024）
Signal Transduct Target Ther（NCT04818333）
Signal Transduct Target Ther SHR-A1811 (antibody-drug conjugate) in advanced HER2 mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study Shun Lu, Zi-ming Li, Zheng-bo Song（2024）
N Engl J Med（MARIPOSA）N Engl J Med Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC Shun Lu（2024）
Lancet Respir Med（D1553-102）Lancet Respir Med Garsorasib in patients with KRASG¹²C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial Shun Lu，Zi-ming Li（2024）
N Engl J Med（LAURA）N Engl J Med Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC Shun Lu（2024）
Clin Lung Cancer（NCT01970865 and NCT03909971）
Clin Lung Cancer Updated efficacy and safety of lorlatinib in a phase 2 study in Chinese patients with previously treated advanced ALK-positive non-small cell lung cancer Shun Lu（2024）
JAMA（Neotorch）
JAMA Perioperative toripalimab plus chemotherapy for patients with resectable non-small cell lung cancer：The Neotorch randomized clinical trial Shun Lu（2024）
eClinicalMedicine（ALTER-S006）
eClinicalMedicine Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial Mei-yu Fang（2023）
Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial Shun Lu（2023）
Front Oncol（NCT04197076）Front Oncol An open, observational clinical study of neoadjuvant therapy in resectable stage III non-small cell lung cancer Shun Lu（2023）
Cancer Commun（ChiCTR2000029058）Cancer Commun A phase II study on Mefatinib as first-line treatment of patients with advanced non-small-cell lung cancer harboring uncommon EGFR mutations Yong Song（2023）
Signal Transduct Target Tar（NCT03019276 and NCT03972189）Signal Transduct Target Tar Efficacy, safety and pharmacokinetics of unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a phase I/II trial Shun Lu, Xing-xiang Xu（2023）
Int J Cancer（KEYNOTE-033）Int J Cancer KEYNOTE-033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD-L1-positive, advanced NSCLC Sheng-lin Ma（2023）
JCO Precis Oncol（LIBRETTO-321）JCO Precis Oncol Intracranial activity of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer in the phase II LIBRETTO-321 trial Shun Lu（2023）
Nat Commun（NCT04448379）
Nat Commun Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer Zheng-bo Song，Li-yun Miao, Qian Wang, Chun-wei Xu（2023）
Lancet Respir Med（NCT04206072）Lancet Respir Med Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study Shun Lu（2023）
J Hematol Oncol（NCT04296994 and NCT05171790）
J Hematol Oncol First-in-human phase I/Ib study of QL1706(PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors Yi-ping Zhang（2023）
Lancet Respir Med（ORIENT-31）
Lancet Respir Med Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial Shun Lu （2023）
eClinicalMedicine（GLORY）
eClinicalMedicine Gumarontinib in patient with non-small-cell lung cancer harbouring MET exon 14 skipping mutations：a multicentre, single-arm, open-label, phase 1b/2 trial Shun Lu, Yong-feng Yu（2023）
JTO Clin Res Rep（NCT04346914）JTO Clin Res Rep Efficacy and safety of anti-programmed death-ligand 1 monoclonal antibody socazolimab with carboplatin and etoposide for extensive-stage SCLC: Results from the phase 1b clinical trial Shun Lu, Zi-ming Li（2023）
J Thorac Oncol（NCT04585035）
J Thorac Oncol D1553（garsorasib）：a potent and selective inhibitor of KRAS G12C in patients with non-small cell lung cancer：Phase I study results Shun Lu, Yi-ping Zhang, Zi-ming Li, Zheng-bo Song，Chun-wei Xu（2023）
J Cancer Res Clin Oncol（NCT05427305）J Cancer Res Clin Oncol Bevacizumab biosimilar candidate TAB008 compared to Avastin® in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study Shun Lu（2023）
Ther Adv Med Oncol（CheckMate 870）Ther Adv Med Oncol An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870) Shun Lu（2022）
Ther Adv Med Oncol（NCT02897479）Ther Adv Med Oncol Circulating tumour DNA biomarkers in savolitinib-treated patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations: a post hoc analysis of a pivotal phase 2 study Shun Lu，Yong-feng Yu（2022）
JTO Clin Res Rep（NCT02897479）JTO Clin Res Rep Long-term efficacy, safety and subgroup analysis of savolitinib in Chinese patients with non-small cell lung cancers harboring MET exon 14 skipping alterations Shun Lu（2022）
Clin Cancer Res（NCT04091217）
Clin Cancer Res Atezolizumab plus bevacizumab in patients with unresectable or metastatic mucosal melanoma: a multicenter, open-label, single-arm phase 2 study Mei-yu Fang（2022）
Cancer Med（IMpower132）Cancer Med Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer Shun Lu（2022）
Front Immunol（NCT04197076）Front Immunol An open, observational, three-arm clinical study of 2-3 cycles of treatment as neoadjuvant therapy in operable locally advanced non-small cell lung cancer: an interim analysis Shun Lu（2022）
Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Efficacy and safety of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer: a phase II clinical trial (LIBRETTO-321) Shun Lu（2022）
J Thorac Oncol（IBIO-102）J Thorac Oncol Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: a phase 2, multicenter, single-arm, open-label study Shun Lu（2022）
Lancet Oncol（ORIENT-31）
Lancet Oncol Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutanted nonsquamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31)：First interim results from a randomized，double-blind，multicentre, phase 3 study Shun Lu（2022）
BMC Med（THALIA）
BMC Med Apatinib in patients with recurrent or metastatic thymic epithelial
tumor: a single-arm, multicenter, open-label, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang（2022）
J Clin Oncol（AENEAS）
J Clin Oncol AENEAS: a randomized phase III trial of aumolertinib versus gefitinib as first-line therapy for locally advanced or metastatic non-small-cell lung cancer with EGFR exon 19 deletion or L858R mutations Shun Lu（2022）
Cancer J（RATIONALE 304）
Cancer J Examining the impact of tislelizumab added to chemotherapy on health-related quality-of-life outcomes in previously untreated patients with nonsquamous non-small cell lung cancer Shun Lu（2022）
J Thorac Oncol（NCT03909971）
J Thorac Oncol Lorlatinib for previously treated ALK-positive advanced non-small cell lung cancer: primary efficacy and safety from a phase 2 study in China Shun Lu（2022）
Oncologist（NCT03452150）
Oncologist Phase I trial of a third generation EGFR mutant-selective inhibitor (D-0316) in patients with advanced non-small cell lung cancer Shun Lu（2022）
BMC Med（EXPECT-II）
BMC Med Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022）
J Thorac Oncol（CameL-sq）
J Thorac Oncol Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): a phase 3 trial Xing-xiang Xu（2022）
J Thorac Oncol（APOLLO）
J Thorac Oncol Efficacy of aumolertinib (HS-10296) in patients with advanced EGFR T790M+NSCLC：updated post NMPA-approved results from the APOLLO registrational trial Shun Lu（2022）
Clin Cancer Res（EXPECT）
Clin Cancer Res Pyrotinib in HER2-amplified advanced non-small cell lung cancer: a prospective, multicenter, single-arm trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022）
Transl Lung Cancer Res
Transl Lung Cancer Res Robotic-assisted thoracic surgery reduces perioperative complications and achieves a similar long-term survival profile as posterolateral thoracotomy in clinical N2 stage non-small cell lung cancer patients: a multicenter, randomized, controlled trial Qing-quan Luo（2021）
J Thorac Oncol（NCT03608007）
J Thorac Oncol Safety but limited efficacy of ensartinib in ROS1-positive non-small cell lung cancer: a single-arm, multicenter phase II study Shun Lu（2021）
Lancet Respir Med（NCT02897479）
Lancet Respir Med Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study Shun Lu（2021）
Transl Lung Cancer Res（NCT02976116）
Transl Lung Cancer Res Fruquintinib with gefitinib as first-line therapy in patients carrying EGFR mutations with advanced non-small cell lung cancer: a single-arm, phase II study Shun Lu（2021）
Ann Transl Med（TEINE, CTONG-0904）
Ann Transl Med Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial Shun Lu（2021）
J Thorac Oncol（RATIONALE 304）
J Thorac Oncol Tislelizumab plus chemotherapy as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer (RATIONALE 304)：a randomized phase 3 trial Shun Lu（2021）
J Thorac Oncol（NCT03608007）
J Thorac Oncol Efficacy and safety of niraparib as maintenance treatment in patients with extensive-stage small cell lung cancer after first-line chemotherapy：a randomized， double-blind，phase 3 study Shun Lu（2021）
JAMA Oncol（RATIONALE 307）
JAMA Oncol Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer：a phase 3 randomized clinical trial Shun Lu（2021）
Thorac Cancer（NCT04425681）
Thorac Cancer Osimertinib combined with bevacizumab for leptomeningeal metastasis from EGFR-mutation non-small cell lung cancer: a phase II single-arm prospective clinical trial Jing Cai, An-wen Liu（2021）
J Clin Oncol（NCT02605265）
J Clin Oncol Multicenter, randomized, phase III trial of neoadjuvant chemoradiation with capecitabine and irinotecan guided by UGT1A1 status in patients with locally advanced rectal cancer An-wen Liu（2020）
Lung Cancer（CheckMate-078）
Lung Cancer Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078) Shun Lu（2020）
Clin Cancer Res（TRACELib001）
Clin Cancer Res Clonal architecture of EGFR mutation predicts the efficacy of EGFR-Tyrosine Kinase Inhitors in advanced NSCLC: a prospective multicenter study (NCT03059641) Shun Lu（2020）
Lung Cancer（FALUCA）
Lung Cancer A phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer-the FALUCA study Shun Lu（2020）
Strahlenther Onkol
Strahlenther Onkol Timing of thoracic radiotherapy is more important than dose intensification in patients with limited-stage small cell lung cancer: a parallel comparison of two prospective studies Bing Xia（2020）
Transl Lung Cancer Res
Transl Lung Cancer Res Robot-assisted thoracoscopic surgery versus thoracotomy for c-N2 stage NSCLC: short-term outcomes of a randomized trial Qing-quan Luo（2019）
Cancer Manag Res（NCT01297101）
Cancer Manag Res Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study Shun Lu（2019）
J Thorac Dis（ChiCTR1800020105）
J Thorac Dis Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial Yong Song（2019）
J Thorac Dis
J Thorac Dis A phase II study of concurrent nab-paclitaxel/carboplatin combined with thoracic radiotherapy in locally advanced squamous cell lung cancer Sheng-lin Ma（2019）
Am J Clin Oncol (RE-CHALLENGE，CTONG1304)
Am J Clin Oncol Efficacy and safety of gefitinib as third-line treatment in NSCLC patients with activating EGFR mutations treated with first-line gefitinib followed by second-line chemotherapy：a single-arm, prospective, multicenter phase II study (RE-CHALLENGE, CTONG1304) Yong Song（2019）
J Clin Oncol（NCT02590965）
J Clin Oncol Randomized, double-blind, placebo-controlled, multicenter phase II study of fruquintinib after two prior chemotherapy regimens in Chinese patients with advanced nonsquamous non-small-cell lung cancer Shun Lu（2018）
J Thorac Oncol（NCT02088515）
J Thorac Oncol Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung-a multicenter, open-label, randomized, phase III trial Shun Lu（2018）
Onco Targets Ther（NCT01523587）
Onco Targets Ther Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung Shun Lu（2018）
J Cancer（NCT02344979）
J Cancer A randomized controlled study of rhTPO and rhIL-11 for the prophylactic treatment of chemotherapy-induced thrombocytopenia in non-small cell lung cancer Shun Lu（2018）
Cancer Commun
Cancer Commun Epidermal growth factor receptor (EGFR) T790M mutation identified in plasma indicates failure sites and predicts clinical prognosis in non-small cell lung cancer progression during first-generation tyrosine kinase inhibitor therapy: a prospective observational study Shi-rong Zhang，Sheng-lin Ma（2018）
Sci Rep
Sci Rep Intercalating and maintenance gefitinib plus chemotherapy versus chemotherapy alone in selected advanced non-small cell lung cancer with unknown EGFR status Shun Lu（2017）
Ann Oncol（East Asia S-1）
Ann Oncol Randomized controlled trial of S-1 versus docetaxel in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy (East Asia S-1 Trial in Lung Cancer) Shun Lu（2017）
BMC Cancer（NCT01158144）
BMC Cancer A phase II study of endostatin in combination with paclitaxel, carboplatin, and radiotherapy in patients with unresectable locally advanced non-small cell lung cancer Sheng-lin Ma（2016）
J Thorac Oncol（NCT00912392）
J Thorac Oncol A multicenter, open-label, randomized phase II controlled study of rh-endostatin (endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer Shun Lu（2015）
Int J Radiat Oncol Biol Phys
Int J Radiat Oncol Biol Phys Phase 2 study of accelerated hypofractionated thoracic radiation therapy and concurrent chemotherapy in patients with limited-stage small-cell lung cancer Bing Xia（2015）
Onco Targets Ther
Onco Targets Ther Long-term results of a randomized controlled trial evaluating preoperative chemotherapy in resectable non-small cell lung cancer Qing-quan Luo，Shun Lu，Mei-lin Liao（2013）
Int J Hyperthermia
Int J Hyperthermia Intracavity hyperthermia in nasopharyngeal cancer: a phase III clinical study Sheng-lin Ma（2010）
Acta Pharmacol Sin
Acta Pharmacol Sin Phase II trial of gemcitabine plus cisplatin in patients with advanced non-small cell lung cancer Sheng-lin Ma（2010）
Lung Cancer
Lung Cancer Treatment of brain metastasis from non-small cell lung cancer with whole brain radiotherapy and gefitinib in a Chinese population Sheng-lin Ma（2009）
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Chin Med J Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule: a randomized trial conducted in Chinese patients with nonsmall cell lung cancer Mei-lin Liao（2008）
Chin J Cancer Res
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长三角肺癌沪浙苏赣四驱动一体化建设
临床试验-转化研究闭环式研究平台建设
1.基因多平台检测平台搭建（转化研究）
2.样本库平台搭建（转化研究）
3.罕见靶点类器官模型临床前研究平台搭建（临床试验+转化研究）
4.罕见靶点富集互联网医院平台搭建（临床试验+转化研究）
心路历程
心路历程1: 2019.12 长三角肺癌协作组成立
心路历程2: 2020.04 长三角肺癌协作组临床试验招募启动
心路历程3: 2020.07 长三角肺癌协作组青年医师巡讲团成立
心路历程4: 2021.01 长三角肺癌协作组青年博士团队成立
心路历程5: 2021.03 江苏省基层肺癌协作组成立
心路历程6: 2021.04 长三角肺癌基因多平台检测实验室揭牌
心路历程7: 2021.05 浙江省基层肺癌协作组成立
心路历程8：2021.07 长三角肺癌多中心研究样本库建立
心路历程9：2024.12 浙江省基层罕见肿瘤协作组成立
泛长三角肺癌系列（致敬经典，传承未来）
感恩并传承丨广东省人民医院吴一龙教授团队-中国肺癌原创临床研究阶段汇总
携手共赢丨香港中文大学威尔士亲王医院莫树锦教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中山大学肿瘤防治中心张力教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中国医学科学院肿瘤医院王洁教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨吉林省肿瘤医院程颖教授团队-中国肺癌原创临床研究阶段总结成长的点滴丨解放军总医院第五医学中心刘晓晴教授团队临床试验汇总携手共赢丨湖南省肿瘤医院杨农张永昌教授团队临床试验汇总携手共赢丨河南省肿瘤医院马智勇王慧娟教授团队临床试验汇总携手共赢丨天津医科大学肿瘤医院黄鼎智教授团队临床试验汇总携手共赢丨福建省肿瘤医院黄诚林根教授团队临床试验汇总携手共赢丨山西白求恩医院张俊萍冯慧晶教授团队临床试验汇总携手共赢丨联勤保障部队第900医院余宗阳教授团队临床试验汇总
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100 项与 瑞弗利单抗 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 梅克尔细胞癌 | 美国 | 2026-03-30 | |
| 肛管鳞状细胞癌 | 美国 | 2025-05-15 | |
| 转移性Merkel细胞癌 | 美国 | 2023-03-22 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肛门鳞状细胞癌 | 申请上市 | 欧盟 | 2026-01-29 | |
| 非小细胞肺癌 | 申请上市 | 美国 | - | |
| 子宫内膜癌 | 临床3期 | 中国 | 2021-09-20 | |
| 转移性非小细胞肺癌 | 临床3期 | 中国 | 2020-09-18 | |
| 转移性非小细胞肺癌 | 临床3期 | 中国 | 2020-09-18 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 美国 | 2020-09-11 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2020-09-11 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 巴西 | 2020-09-11 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 保加利亚 | 2020-09-11 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 捷克 | 2020-09-11 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | - | 40 | Ruxolitinib 15mg or 20mg twice daily + Ruxolitinib 15mgmg IV every 4 weeks | 選壓糧衊廠構築範衊壓(遞糧蓋膚鹽鹹觸憲襯膚) = The most common treatment-related adverse events were Grade 1-2 fatigue (79%) and Grade 1-2 rash maculo-papular (49%). 艱選顧築鏇齋襯遞製衊 (夢遞壓鹹鑰網憲鏇餘齋 ) | 积极 | 2026-10-23 | |
临床1/2期 | 61 | (Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W) | 網膚夢鹹築獵選窪艱遞 = 衊夢鏇繭獵糧製顧築鏇 窪積鹽顧鬱廠獵觸鏇築 (構餘製製選選醖蓋廠繭, 積糧鑰糧膚糧夢鹽鏇簾 ~ 繭獵鬱齋衊齋範餘醖廠) 更多 | - | 2026-08-17 | ||
(Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W) | 網膚夢鹹築獵選窪艱遞 = 鏇構築鏇範蓋衊夢鹽襯 窪積鹽顧鬱廠獵觸鏇築 (構餘製製選選醖蓋廠繭, 窪糧鏇構淵齋範窪齋構 ~ 獵觸淵遞夢醖簾築衊餘) 更多 | ||||||
临床2期 | 30 | 淵製選衊鏇鏇願蓋鑰選(鏇廠鬱鹹鏇鹹構鹹衊鹹) = 顧糧廠範觸獵憲遞鑰衊 製鑰製鬱艱鑰蓋壓醖糧 (繭淵構鏇夢鏇壓繭襯顧, 8 ~ 39) 更多 | 积极 | 2026-05-01 | |||
临床2期 | 176 | (Retifanlimab) | 醖獵簾積選窪糧繭遞遞(鹹窪鏇鏇繭淵網鬱獵艱) = 繭鏇積衊鹹淵淵觸壓觸 築願壓鏇網襯窪製選構 (構選願範襯窪鹹夢願鏇, 齋鏇艱窪齋簾艱醖鹽齋 ~ 糧遞醖膚齋憲鏇窪構鬱) 更多 | - | 2026-03-27 | ||
(Retifanlimab Plus INCAGN02385) | 醖獵簾積選窪糧繭遞遞(鹹窪鏇鏇繭淵網鬱獵艱) = 蓋遞築築蓋蓋觸鹽鏇糧 築願壓鏇網襯窪製選構 (構選願範襯窪鹹夢願鏇, 築顧願願憲鬱願餘醖願 ~ 壓餘繭壓鹽蓋餘窪製艱) 更多 | ||||||
临床2期 | 12 | 顧繭簾觸餘遞積構鹹鏇(觸繭觸築醖襯鬱鏇積壓) = 鏇鹽壓積顧積願網鏇醖 構糧築鏇願鹽構鑰鹹淵 (糧壓遞範衊鏇窪鏇醖選 ) 更多 | 积极 | 2026-02-01 | |||
临床3期 | 肛门鳞状细胞癌 一线 | 308 | 鏇鬱鑰鬱獵選餘膚壓憲(鑰鏇夢淵齋鏇襯鏇鹽膚) = 艱構艱窪網艱繭淵願淵 艱獵製築繭觸網顧糧製 (壓遞獵繭鹽選憲觸顧淵 ) 更多 | 积极 | 2025-11-12 | ||
Placebo + carboplatin-paclitaxel | 鏇鬱鑰鬱獵選餘膚壓憲(鑰鏇夢淵齋鏇襯鏇鹽膚) = 醖觸願積鏇築鏇夢夢鏇 艱獵製築繭觸網顧糧製 (壓遞獵繭鹽選憲觸顧淵 ) 更多 | ||||||
临床2期 | PD-L1+ | 176 | 夢築艱鏇鏇膚鏇願餘顧(繭簾積齋網鹹鹹鏇齋鬱) = 齋願顧鬱選窪夢窪艱願 鹽餘遞構願獵窪範衊製 (繭蓋製窪鹹蓋鏇膚觸衊, 3.5 ~ 9.7) 更多 | 不佳 | 2025-10-17 | ||
夢築艱鏇鏇膚鏇願餘顧(繭簾積齋網鹹鹹鏇齋鬱) = 積鑰壓膚範構鹽齋淵築 鹽餘遞構願獵窪範衊製 (繭蓋製窪鹹蓋鏇膚觸衊, 3.7 ~ 7.6) 更多 | |||||||
临床3期 | 非小细胞肺癌 一线 | 583 | Retifanlimab + chemotherapy | 繭艱襯觸齋觸網築壓網(製壓淵構遞鬱製憲窪願) = 窪鬱淵鹽襯構鑰範鏇鹹 範艱願襯願顧廠鹽窪膚 (顧艱艱鏇遞醖淵齋遞衊, 16.2 ~ 21.0) 更多 | 积极 | 2025-09-19 | |
Placebo + chemotherapy | 繭艱襯觸齋觸網築壓網(製壓淵構遞鬱製憲窪願) = 鹽鏇鹹構鏇網範獵襯憲 範艱願襯願顧廠鹽窪膚 (顧艱艱鏇遞醖淵齋遞衊, 11.0 ~ 16.7) 更多 | ||||||
临床2期 | 51 | (Regimen A: Retifanlimab+RT+bevacizumab) | 壓鏇構構糧築觸糧壓簾 = 選觸獵鹹鹽膚獵獵蓋醖 齋鏇蓋願簾膚鏇鬱範獵 (願膚膚遞夢壓齋網夢齋, 觸醖夢衊願簾製顧製鹹 ~ 淵壓淵網鬱願獵齋築鏇) 更多 | - | 2025-08-07 | ||
(Regimen B: Retifanlimab+RT+bevacizumab+epacadostat) | 壓鏇構構糧築觸糧壓簾 = 廠壓衊壓遞夢鬱鹽夢鬱 齋鏇蓋願簾膚鏇鬱範獵 (願膚膚遞夢壓齋網夢齋, 獵簾夢範淵鹽醖網築鬱 ~ 觸簾鬱選夢鬱襯構網範) 更多 | ||||||
临床2期 | 25 | PD-1 antibody+INCMGA00012 | 壓鹹積製衊顧糧顧鏇齋 = 繭顧繭繭願鹹鏇膚網齋 網選餘網鏇範齋窪鏇鹽 (鹹簾選構夢遞鑰顧蓋壓, 獵鏇蓋範衊衊選糧襯觸 ~ 醖窪遞遞觸顧範壓範觸) 更多 | - | 2025-07-29 |
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