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

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT05132777
Phase
PHASE2
Status
Unknown

Conditions

  • EGFR Exon20 Insertion Mutations
  • Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JMT101 — DRUG
    JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
  • Osimertinib Mesylate Tablets — DRUG
    Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).

Study Details

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Key Dates

Start date
Nov 20, 2021
Status verified
Nov 2021
Primary completion
Sep 30, 2023
Completion
Sep 30, 2024

Study Design

Enrollment
155 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: JMT101 in combination with Osimertinib

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 [ Time Frame: From the first dose to disease progression or end of study, an average of 1 year ]

Central Contacts

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