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Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment

NCT04882345 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-11

No results posted yet for this study

Summary

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of Almonertinib treatment in patients with EGFR mutation positive and advanced non-small cell lung cancer (NSCLC) who are intolerant to the safety of osimertinib treatment.

Conditions

Interventions

DRUG

Almonertinib

Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Yongsheng Li · The Affiliated Cancer Hospital of Chongqing University

  • Jianying Zhou · Zhejiang University

  • Xiuyu Cai · Sun Yat-sen University

  • Yueyin Pan · The First Affiliated Hospital of University of Science and Technology of China

  • Wenxiu Yao · Sichuan Cancer Hospital and Research Institute

  • Chun Huang · Tianjin Cancer Hospital

  • Minglei Zhuo · Peking University Cancer Hospital & Institute

  • Conghua Xie · Wuhan University

  • Meiqi Shi · Jiangsu Cancer Institute & Hospital

  • Qibin Song · Hubei Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2024-01-15
Completion
2024-01-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882345 on ClinicalTrials.gov