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A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Chinese Pla General Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, China
Start Date
June 29, 2020
Primary Completion Date
December 31, 2021
Completion Date
June 30, 2022
Last Updated
December 28, 2020
48
ESTIMATED participants
JMT101
DRUG
Lead Sponsor
Shanghai JMT-Bio Inc.
Collaborators
NCT06955988
NCT05132777
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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