Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
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
1 other identifier
interventional
48
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2020
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
June 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedDecember 28, 2020
July 1, 2020
1.5 years
June 16, 2020
December 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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
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
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
- +5 more secondary outcomes
Study Arms (2)
Dose Escalation Cohort
EXPERIMENTALTwo 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).
Dose Expansion Cohort
EXPERIMENTALOnce the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
Interventions
IV infusion Q2W for 4 weeks (28-day cycles)
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, 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
Related Publications (1)
Zhao S, Zhuang W, Han B, Song Z, Guo W, Luo F, Wu L, Hu Y, Wang H, Dong X, Jiang D, Wang M, Miao L, Wang Q, Zhang J, Fu Z, Huang Y, Xu C, Hu L, Li L, Hu R, Yang Y, Li M, Yang X, Zhang L, Huang Y, Fang W. Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. Nat Commun. 2023 Jun 12;14(1):3468. doi: 10.1038/s41467-023-39139-4.
PMID: 37308490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 25, 2020
Study Start
June 29, 2020
Primary Completion
December 31, 2021
Study Completion
June 30, 2022
Last Updated
December 28, 2020
Record last verified: 2020-07