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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Beijing Cancer Hospital
Beijing, China
NOT_YET_RECRUITINGProgression Free Survival (PFS)
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).
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Assess the anti-tumor activity: OS
Overall survival (OS)
Time frame: Start of study drug to Survival Endpoint through study completion, an average of 4 years.
Assess the anti-tumor activity: ORR
Objective response rate (ORR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
Assess the anti-tumor activity: DCR
Disease control rate (DCR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.
Assess the anti-tumor activity: DoR
Duration of response (DoR)
Time frame: DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.
Assess the safety of Almonertinib : Number of AEs/SAEs
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Beijing Chest Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, China
NOT_YET_RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, China
NOT_YET_RECRUITINGXinqiao Hospital, Army Medical University
Chongqing, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGFujian Provincial Hospital
Fuzhou, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital
Hangzhou, China
NOT_YET_RECRUITINGThe second Affiliated Hospital of Kunming Medical University
Kunming, China
NOT_YET_RECRUITING...and 8 more locations
Number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: Continuously throughout the study until 28 days after Termination of the treatment
QoL QoL
To assess disease-related symptoms and QoL in overall population as well as in pre-specified subgroups
Time frame: 2 years
Assess the anti-tumor activity: iORR
Intracranial Objective response rate (iORR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
Assess the anti-tumor activity: iDCR
Intracranial Disease control rate (iDCR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
Intracranial Progression Free Survival (iPFS)
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).
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.