Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

Locally Advanced or Metastatic Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448379
• Other study ID #: JMT101-CSP-001
• Status: Recruiting
• Phase: Phase 1
• Start date: June 29, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2020
• Source: Shanghai JMT-Bio Inc.
• Contact: Xiugao Yang
• Phone: 8021-60677906
• Email: yangxiugao[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced or Metastatic Non-Small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• JMT101
IV infusion Q2W for 4 weeks (28-day cycles)

Locations

Country	Name	City	State
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	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
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	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
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

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disease control rate (DCR).		From first dose to disease progression or end of study, an average of 1 year
Secondary	Progression free survival (PFS).		From first dose to disease progression or end of study, an average of 1 year
Secondary	Overall survival (OS).		From first dose to death or end of study, an average of 1 year
Secondary	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
Secondary	Maximum measured plasma concentration (Cmax) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Time to maximum plasma concentration (Tmax) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Half-life (T1/2) of JMT101.		From enrollment until 30 days after the last dose
Secondary	Immunogenicity profile of JMT101.	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.	From enrollment until 30 days after the last dose
Secondary	Potential biomarkers detected in plasma circulating tumor DNA.		From enrollment up to disease progression, an average of 1 year