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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338243
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Haihe Biopharma Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Negative T790M Mutation and Met Amplification Drug: Glumetinib Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. OS(Overall survival) [ Time Frame: Through study completion, an average of 1 year ]
    The time from the patient first dose to death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338243


Contacts
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Contact: Shun LU, Doctor +86-21-22200000 ext 2153 shun_lu@hotmail.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Ziping Wang, Doctor         
Sponsors and Collaborators
Haihe Biopharma Co., Ltd.
Investigators
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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
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Responsible Party: Haihe Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04338243    
Other Study ID Numbers: SCC244-203
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haihe Biopharma Co., Ltd.:
MET amplification, T790
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases