RecruitingC-Met Exon 14 Mutation

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

Eligible age

18–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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)

Sponsor: Haihe Biopharma Co., Ltd.

You may qualify if…

✓ 1. Provide informed consent voluntarily.
✓ 2. Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is \> 18 years).
✓ 3. Histologically or cytologically confirmed diagnosis of NSCLC including PSC.
✓ 4. Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8).
✓ 5. For Phase Ib study, patients should carry at least one of the following MET alterations (by local or Sponsor-designated central laboratory screening):
✓ METex14 skipping mutation who had previously treated by other MET inhibitor(s) or
✓ METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC or
✓ MET amplification GCN ≥ 4 or MET/CEP7 ratio ≥ 2) or

You may not qualify if…

✕ Patients who meet any of the following criteria shall be excluded from the study:
✕ 1. Patients with targetable activating EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF mutation or NTRK fusion that have available standard of care therapies.
✕ 2. 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 with treatment dose no more than dexamethasone 4 mg daily or an equivalent dose of steroids.)
✕ 3. Prior exposure to MET-directed therapy (except patients harboring METex14 skipping in Phase Ib study).
✕ 4. Evidence of past or current primary malignancies other than NSCLC (except for non-melanoma skin cancer, in situ breast cancer or in situ cervical carcinoma and superficial bladder cancer, or other cancer curatively treated and with no evidence of disease for at least 5 years).
✕ 5. Subjects with clinically significant cardiovascular disease, including:
✕ NYHA Class III or higher congestive heart failure;
✕ History or current evidence of serious uncontrolled ventricular arrhythmias requiring drug therapy;

Where it's recruiting

Kentucky

Louisville

Source: ClinicalTrials.gov · NCT04270591 · last updated 2022-08-01