Almonertinib

Generic Name: Almonertinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₅N_₇O_₂

CAS Number: 1899921-05-1

Unique Ingredient Identifier: T4RS462G19

Background: Almonertinib is a third-generation EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing and T790M resistance mutations. It is being investigated against advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).

Indication: 1.用于既往经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M 突变阳性的局部晚期或转移性非小细胞肺癌成人患者的治疗。

2.用于表皮生长因子受体（EGFR）敏感突变阳性局部晚期或转移性非小细胞肺癌（NSCLC）患者一线治疗。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer

Phase 2

Not yet recruiting

Conditions: Lung Cancer Non-small Cell Stage IV

Interventions: Drug: Almonertinib

First Posted Date: 2024-06-17

Last Posted Date: 2024-06-17

Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Target Recruit Count: 60

Registration Number: NCT06463171

Locations: 🇨🇳
Zhongshan hospital, Shanghai, China
🇨🇳
The First Affiliated Hospital of Xiamen University, Xiamen, China

Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Phase 2

Recruiting

Conditions: Non Small Cell Lung Cancer
EGFR Gene Mutation

Interventions: Drug: almonertinib
Drug: Carboplatin
Drug: Nab paclitaxel

First Posted Date: 2024-03-08

Last Posted Date: 2024-04-17

Lead Sponsor: Guangdong Provincial People's Hospital

Target Recruit Count: 32

Registration Number: NCT06300424

Locations: 🇨🇳
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China

Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance

Phase 3

Recruiting

Conditions: Advanced Non-small Cell Lung Cancer

Interventions: Drug: almonertinib

First Posted Date: 2023-09-21

Last Posted Date: 2023-09-21

Lead Sponsor: Qianfoshan Hospital

Target Recruit Count: 98

Registration Number: NCT06043973

Locations: 🇨🇳
Degan Lu, Jinan, Shandong, China

Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer

Phase 2

Not yet recruiting

Conditions: Lung Cancer Stage III

Interventions: Drug: Almonertinib

First Posted Date: 2023-08-16

Last Posted Date: 2023-08-29

Lead Sponsor: Laibin People's Hospital

Target Recruit Count: 40

Registration Number: NCT05994339

Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

Phase 1

Recruiting

Conditions: Malignant Tumor of Lung
Poor Performance Status

Interventions: Drug: Almonertinib

First Posted Date: 2023-04-24

Last Posted Date: 2023-04-24

Lead Sponsor: Guangzhou Institute of Respiratory Disease

Target Recruit Count: 20

Registration Number: NCT05826483

Locations: 🇨🇳
Zhou Chengzhi, Guangzhou, Guangdong, China

Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer Metastatic

Interventions: Drug: Almonertinib
Radiation: SBRT

First Posted Date: 2023-04-05

Last Posted Date: 2023-04-05

Lead Sponsor: Shanghai Cancer Hospital, China

Target Recruit Count: 300

Registration Number: NCT05800223

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

Phase 3

Recruiting

Conditions: Brain Metastases
Radiotherapy
EGFR Activating Mutation

Interventions: Radiation: brain radiotherapy
Drug: Almonertinib

First Posted Date: 2023-03-14

Last Posted Date: 2023-03-14

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 232

Registration Number: NCT05768490

Locations: 🇨🇳
Sun-Yat-Sen university, Guangdong, Guangzhou, China

Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Almonertinib

First Posted Date: 2022-12-23

Last Posted Date: 2022-12-23

Lead Sponsor: West China Hospital

Target Recruit Count: 55

Registration Number: NCT05662813

Locations: 🇨🇳
West China Hospital，Sichuan University, Chendu, Sichuan, China

Almonertinib Plus Metronomic Oral Vinorelbine

Not yet recruiting

Conditions: EGFR
Third-generation TKI
NSCLC

Interventions: Drug: Almonertinib and metronomic oral vinorelbine

First Posted Date: 2022-12-23

Last Posted Date: 2022-12-23

Lead Sponsor: Fujian Cancer Hospital

Target Recruit Count: 40

Registration Number: NCT05663177

Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer

Phase 1

Not yet recruiting

Conditions: Relapsed or Advanced Non-small Cell Lung Cancer

Interventions: Drug: Almonertinib combined with SHR-1701
Drug: Almonertinib

First Posted Date: 2022-08-17

Last Posted Date: 2022-08-17

Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Target Recruit Count: 160

Registration Number: NCT05503888

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