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

NCT04338243 | Unknown Phase 1 DMC

• 1 other identifier: SCC244-203
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Negative T790M Mutation and Met Amplification

Keywords

MET amplification， T790

Outcome Measures

Primary Outcomes (1)

• ORR(Objective response rate)

  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 Outcomes (3)

• ORR(Objective response rate, assessed as per investigators)

  through study completion, an average of 1 year

• DOR(Duration of response)

  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)

  Through study completion, an average of 1 year

Study Arms (1)

Glumetinib+Osimertinib

EXPERIMENTAL

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

Interventions

Glumetinib DRUG

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

Glumetinib+Osimertinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haihe Biopharma Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Interventions

glumetinib

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shun LU, Doctor

CONTACT

+86-21-22200000; shun_lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase Ib: Glumetinib 300mg Combined With Osimertinib 80mg, Qd ,oral

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 8, 2020
• Study Start: November 18, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-03

Locations

CN (1)