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

Conditions

• Harboring EGFR Common Mutation
• Local Advanced or Metastatic NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Nov 21, 2021

Status verified

Apr 2024

Primary completion

May 17, 2023

Completion

Nov 21, 2026

Study Design

Enrollment

161 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: JMT101 combined with Osimertinib
  JMT101 6mg/kg iv Q2W or Q3W, osimertinib 80mg or 160mg po QD until a treatment discontinuation criterion is met.

Primary Outcome Measure

Adverse events incidence and severity [ Time Frame: Up to approximately 60 months after the first participant was enrollment ]