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Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

NCT04338243 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-08

No results posted yet for this study

Summary

To explore the safety and efficacy of Glumetinib combined with Osimertinib in the treatment of relapsed and metastatic non-small cell lung cancer (NSCLC) with failed first-generation or second-generation EGFR inhibitors, negative T790M mutation and met amplification.

Conditions

  • Negative T790M Mutation and Met Amplification

Interventions

DRUG

Glumetinib

Phase Ib is a dose escalation study, the initial dose of Glumetinib is 300mg, then will be escalated to 400mg，according to the result of Phase Ib， will confirm the RP2D

Sponsors & Collaborators

  • Haihe Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongqian Shu, Doctor · Jiangsu Province People's Hospital

  • Dingzhi Huang, Doctor · Tianjin Cancer Hospital

  • Yiping Zhang, Doctor · Zhejiang Province Cancer Hospital

  • Jianying Zhou, Doctor · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338243 on ClinicalTrials.gov