Study on the Safety and Effectiveness of Glumetinib for Patients with c-MET-positive Non-Small Cell Lung Cancer
Sponsor: Haihe Biopharma Co., Ltd.
ClinicalTrials ID:NCT04270591
This clinical trial is testing a new drug called Glumetinib to see if it is safe and effective for treating patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic marker called c-MET.
Patient Parameters
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Program Overview
The study is focused on patients with advanced non-small cell lung cancer (NSCLC) that is positive for a genetic marker called c-MET. It is being conducted in two phases: Phase Ib, which is only in China and involves about 90 patients, and Phase II, which is global and involves about 78 patients. The trial aims to assess the safety and effectiveness of Glumetinib in these patients.
Description
This study is divided into two phases to evaluate the safety and effectiveness of Glumetinib in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic marker called c-MET.
Phase Ib (China only):
- Involves about 90 patients with advanced NSCLC, including a type called pulmonary sarcomatoid carcinoma (PSC).
- Patients must have certain changes in the MET gene, such as the METex14 skipping mutation or MET amplification.
Phase II (Global):
- Involves about 78 patients worldwide.
- Focuses on patients with the METex14 skipping mutation who are not eligible for chemotherapy or have refused it, or whose cancer has not responded to one or two previous treatments.
The study will help determine if Glumetinib is safe and effective for these patients.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC), including pulmonary sarcomatoid carcinoma (PSC).
- Have advanced NSCLC that cannot be treated with surgery or radiation.
- For Phase Ib, must have specific changes in the MET gene, such as METex14 skipping mutation or MET amplification.
- For Phase II, must have the METex14 skipping mutation and not be eligible for chemotherapy or have refused it.
- Must have at least one measurable tumor.
- Must have good overall health and organ function.
- Must provide a tumor tissue sample for testing.
- Must agree to use effective birth control during the study and for six months after treatment.
Exclusion Criteria
- Have other genetic mutations that have standard treatments available.
- Have unstable brain metastases or need increasing doses of steroids for brain disease.
- Have had previous MET-targeted therapy (except in Phase Ib).
- Have other active cancers, except for certain non-threatening types.
- Have significant heart disease or uncontrolled high blood pressure.
- Have unresolved side effects from previous treatments.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have had recent cancer treatments or major surgery.
- Are pregnant or breastfeeding.
- Are not using effective birth control if of childbearing potential.
- Have other serious medical conditions that could affect the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Norton Cancer Institute | 40233 | Louisville | Kentucky |
| The Oncology Institute of Hope & Innovation | 40233 | Louisville | Kentucky |
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