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Carcinoma, Squamous Cell

Carcinoma, Adenosquamous

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Neoplasms by Histologic Type

Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Almonertinib

Gen Lin

Jun Zhao

Zhe Liu

Zhijie Wang

Lin Wu

Fang Wu

Bo Zhu

Lin Gen

Zhenghua Liu

Yong Fang

Jie Lin

Anwen Liu

XiaoFeng Chen

Yongfeng Yu

Dingzhi Huang

Qian Chu

Hongmei Zhang

Huijuan Wang

Shundong Cang

This is a prospective, multi-center, single-arm clinical trial.

This is a multicenter, single arm, phase II study assessing the efficacy and safety of Almonertinib as first-line treatment in patients with EGFR mutation positive locally advanced or metastatic Pulmonary Adenosquamous Carcinoma.

Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Study (ARISE)

To assess the efficacy of Almonertinib as first line therapy to EGFRm+, locally advanced or metastatic Pulmonary Adenosquamous Carcinoma patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Number of adverse events (AEs)/serious adverse events (SAEs)

To assess disease-related symptoms and QoL in overall population as well as in pre-specified subgroups

Intracranial Objective response rate (iORR)

To assess the efficacy of Almonertinib as first line therapy to EGFRm+, locally advanced or metastatic Pulmonary Adenosquamous Carcinoma patients by assessment of intracranial progression free survival (iPFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Fujian Cancer Hospital

Spots Global Cancer Trial Database for pulmonary adenosquamous carcinoma