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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
IV infusion Q2W for 4 weeks (28-day cycles)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Time frame: From enrollment until 30 days after the last dose
Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Time frame: From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Time frame: From first dose to death or end of study, an average of 1 year
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
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Chinese Pla General Hospital
Beijing, China
RECRUITINGHunan Cancer Hospital
Changsha, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
RECRUITINGJiangsu Province Hospital of Chinese Medicine
Nanjing, China
RECRUITINGNanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
RECRUITINGShanghai Chest Hospital, Shanghai Jiaotong University
Shanghai, China
RECRUITING...and 3 more locations
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Time frame: From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma circulating tumor DNA.
Time frame: From enrollment up to disease progression, an average of 1 year