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Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer

NCT04270591 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2022-08-01

No results posted yet for this study

Summary

Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer

Phase Ib (China only):

Approximately 90 patients

Phase Ⅱ (globally):

Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)

Conditions

  • C-Met Exon 14 Mutation

Interventions

DRUG

Glumetinib

The investigational product will be orally administrated when fasting at dose level of 300mg QD

Sponsors & Collaborators

  • Haihe Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • James Zhou, MD · Haihe Biopharma

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
2019-07-15
Primary Completion
2023-10-25
Completion
2023-12-30
FDA Drug
Yes

Countries

  • United States
  • China
  • Japan

Study Locations

More Related Trials

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 NCT04270591 on ClinicalTrials.gov