Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
- Registration Number
- NCT04448379
- Lead Sponsor
- Shanghai JMT-Bio Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
- No previous treatment or first-line treatment failed NSCLC;
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
- Previously treated with EGFR antibody;
- Symptomatic brain metastasis;
- Interstitial pneumopathy;
- Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
- Receiving an investigational product in another clinical study within 4 weeks;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Expansion Cohort JMT101 Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. Dose Escalation Cohort JMT101 Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
- Primary Outcome Measures
Name Time Method Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)). From enrollment until 30 days after the last dose
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS). From first dose to disease progression or end of study, an average of 1 year Overall survival (OS). From first dose to death or end of study, an average of 1 year Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 From first dose to disease progression or end of study, an average of 1 year Disease control rate (DCR). From first dose to disease progression or end of study, an average of 1 year Half-life (T1/2) of JMT101. From enrollment until 30 days after the last dose Immunogenicity profile of JMT101. From enrollment until 30 days after the last dose Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101. From enrollment until 30 days after the last dose Maximum measured plasma concentration (Cmax) of JMT101. From enrollment until 30 days after the last dose Time to maximum plasma concentration (Tmax) of JMT101. From enrollment until 30 days after the last dose Potential biomarkers detected in plasma circulating tumor DNA. From enrollment up to disease progression, an average of 1 year
Trial Locations
- Locations (13)
Hunan Cancer Hospital
🇨🇳Changsha, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, China
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
🇨🇳Wuhan, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Chinese Pla General Hospital
🇨🇳Beijing, China
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Jiangsu Province Hospital of Chinese Medicine
🇨🇳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
Fujian Cancer Hospital
🇨🇳Fuzhou, China