Clinical trial NCT04448379: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
First posted: 2020-06-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
timeFrame: From enrollment until 30 days after the last dose
Secondary outcomes:
measure: Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Disease control rate (DCR).
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Progression free survival (PFS).
timeFrame: From first dose to disease progression or end of study, an average of 1 year
measure: Overall survival (OS).
timeFrame: From first dose to death or end of study, an average of 1 year
measure: Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Maximum measured plasma concentration (Cmax) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Half-life (T1/2) of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Immunogenicity profile of JMT101.
timeFrame: From enrollment until 30 days after the last dose
measure: Potential biomarkers detected in plasma circulating tumor DNA.
timeFrame: From enrollment up to disease progression, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Beijing
country: China
facility: Chinese Pla General Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiaotong University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
Study officials:
References: