NCT06391944

JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations

A Phase 2, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-Small Cell Lung Cancer With EGFR Common Mutations

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy. Efficacy indexes included investigator-assessed Overall Response Rate(ORR), Disease Control Rate(DCR), Duration of Response( DoR), Progression Free Survival (PFS) per RECIST 1.1 and Overall Survival (OS). Safety indexes included Adverse Events incidence and severity. This study included 4 cohorts, cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mg/Kg Q3W and Osimertinib 80mg QD therapy. Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg QD therapy. Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy. Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy.

Detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Conditions

• Local Advanced or Metastatic NSCLC
• Harboring EGFR Common Mutation

Interventions

Type	Name	Description
DRUG	JMT101 Injection	JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 or 21 days
DRUG	Osimertinib tablet	Osimertinib 80 or 160mg po everyday

Timeline

• Start date: 2021-11-21
• Primary completion: 2023-05-17
• Completion: 2026-11-21
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: China