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

April 7, 2020 updated by: Haihe Biopharma Co., Ltd.

Open Label, Multicenter Phase Ib / II Study of Glumetinib Combined With Osimertinib in the Treatment of Relapsed and Metastatic Non-small Cell Lung Cancer Patients Who Failed to Receive EGFR Inhibitors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Ziping Wang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Can fully understand and sign informed consent form(ICF) voluntarily Male and female patients 18-80 (inclusive) years of age
  • Stage: IIIb/IIIc/IV (AJCC version 8)
  • ECOG Performance Status (PS): 0-1
  • At least one measurable lesion as per RECIST 1.1

Exclusion Criteria:

  • Subjects with characterizedALK or ROS1 activating mutations that predict sensitivity to anti-ALK-therapy or anti-ROS1-therapy; T790 mutations is uknown or positive
  • Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥3 months at least two weeks prior to entering the study.)
  • Prior exposure to MET-directed or third generation EGFR inhibitors therapy Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy
  • Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glumetinib+Osimertinib
The investigational product Glumetinib will be orally administrated when fasting at dose level of 300mg QD and Osimertinib will be orally administrated when fasting at dose level of 80mg QD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR(Objective response rate)
Time Frame: through study completion, an average of 1 year
the sum ratio of partial response and complete response(determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR(Objective response rate, assessed as per investigators)
Time Frame: through study completion, an average of 1 year
the sum ratio of partial response and complete response(assessed as per investigators)
through study completion, an average of 1 year
DOR(Duration of response)
Time Frame: The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months
The time from the partial response and complete response of patient to patient progressive disease or death
The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months
OS(Overall survival)
Time Frame: Through study completion, an average of 1 year
The time from the patient first dose to death
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haihe Biopharma Co., Ltd.

Investigators

  • Principal Investigator: Yongqian Shu, Doctor, Jiangsu Province People's Hospital
  • Principal Investigator: Dingzhi Huang, Doctor, Tianjin Cancer Hospital
  • Principal Investigator: Yiping Zhang, Doctor, Zhejiang Province Cancer Hospital
  • Principal Investigator: Jianying Zhou, Doctor, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCC244-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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