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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaihe Biopharma Co., Ltd.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide informed consent voluntarily.

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).

Histologically or cytologically confirmed diagnosis of NSCLC including PSC.

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).

Disqualifiers

Patients with targetable activating EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF mutation or NTRK fusion that have available standard of care therapies.

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.)

Prior exposure to MET-directed therapy (except patients harboring METex14 skipping in Phase Ib study).

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Glumetinib

    Drug

    The investigational product will be orally administrated when fasting at dose level of 300mg QD

Treatment groups

183 Participants
are divided into 1 treatment group
Group A: SCC244 300mgOther 1 intervention

Trial outcomes

Primary outcomes

1

ORR

ORR as determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

ORR(assessed as per investigators)

ORR (assessed as per investigators)

Time frame
through study completion, an average of 1 year
2

DOR

DOR

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
3

Efficacy of glumetinib

OS

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

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