Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer
NCT05132777 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2021-11-24
Summary
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.
Conditions
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- EGFR Exon20 Insertion Mutations
Interventions
- DRUG
-
JMT101
JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).
- DRUG
-
Osimertinib Mesylate Tablets
Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
collaborator INDUSTRY -
Shanghai JMT-Bio Inc.
lead INDUSTRY
Principal Investigators
-
Li Zhang · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-20
- Primary Completion
- 2023-09-30
- Completion
- 2024-09-30
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