Clinical trial NCT05513664: Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
Official title: To Evaluate Real-World Effectiveness of Osimertinib for Patients With Advanced or Metastatic Epidermal Growth Factor Receptor 20exon Insertion Mutation (20ins) Non-Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer
EGFR Exon20 Insertion Mutations
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
First posted: 2022-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received osimertinib with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.

Brief summary: This study is a retrospective real-world study to evaluate the efficacy of Osimertinib for patients with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer.

Detailed description: This is a multicenter, retrospective observational real-world study, which evaluates the efficacy of Osimertinib, between 2017 and 2022, in patients with advanced or metastatic EGFR 20exon insertion mutation (20ins) Non-Small Cell Lung Cancer. This study serves as the external control for a single arm phase II trial on JMT101 combined with Osimertinib in patients with Non-Small Cell Lung Cancer. The primary outcome measure is objective response rate (ORR).

Eligibility criteria: Inclusion Criteria:

1. Locally advanced or metastatic (stage ШB-Ⅳ, 8th AJCC) NSCLC confirmed by histology or cytology;
2. The result of EGFR 20ins is positive detected by tissue, blood, pleural fluid or cerebrospinal fluid;
3. Have received osimertinib treatment after detection of EGFR 20ins;
4. Age of 18 years or above;
5. Information about tumor outcome evaluation is required at least once after osimertinib treatment (such as tumor imaging data, description of efficacy evaluation in medical records, etc.).

Exclusion Criteria:

1. Previously treated with JMT101 (Patients will be included if osimertinib treatment is before JMT101 treatment);
2. Patients harboring EGFR exon20 insertion mutation and also have other EGFR TKI-sensitizing EGFR mutations, such as G719X mutation in exon 18, exon 19 deletion mutation (19 del), exon 20 T790M or S768I mutation, exon 21 L858R mutation, or L861Q mutation.

Primary outcomes:
measure: 1.Real world Objective Response Rate (rwORR)
timeFrame: March 2017 to May 2022
Secondary outcomes:
measure: Real world Duration of Response（rwDOR）
timeFrame: From March 2017 to May 2022
measure: Real world Disease Control Rate（rwDCR）
timeFrame: From March 2017 to May 2022
measure: Real world Progression Free Survival（rwPFS）
timeFrame: From March 2017 to May 2022
Other outcomes:
Locations:
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Chongqing
country: China
facility: Southwest Hospital of Army Medical University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
city: Hefei
country: China
facility: Anhui Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Chest Hospital
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanxi
country: China
facility: Shanxi Provincial People's Hospital
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
city: Wuhan
country: China
facility: Huazhong University of Science Tongji Hospital, Tongji Medical College
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: