Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGJMT101
IV infusion Q2W for 4 weeks (28-day cycles)
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Shanghai JMT-Bio Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Time to maximum plasma concentration (Tmax) of JMT101. | From enrollment until 30 days after the last dose | — |
| 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. |
| Potential biomarkers detected in plasma circulating tumor DNA. | From enrollment up to disease progression, an average of 1 year | — |
| Maximum measured plasma concentration (Cmax) of JMT101. | From enrollment until 30 days after the last dose | — |
Countries
China
Contacts
Primary ContactXiugao Yang
Backup ContactRong Hu
Outcome results
None listed