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Brief Title: Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT04448379
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences), Taiyuan, , China
Shanxi Province Cancer Hospital, Taiyuan, , China
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology, Wuhan, , China