CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 183 target
Drug / intervention
Glumetinibdrug
Likely dose
Glumetinib 300mgfrom record
Key inclusion· 9
  • ✓Histologically or cytologically confirmed NSCLC including PSC
  • ✓Stage IIIb/IIIc not candidates for surgery/chemoradiation, or stage IV NSCLC (AJCC v8)
  • ✓Phase Ib: METex14 skipping (prior MET inhibitor or ≥3 prior lines without MET inhibitor), or MET amplification (GCN≥4 or ratio≥2), or MET overexpression (IHC2+)
  • ✓Phase II: METex14 skipping in tumor or ctDNA (local or central lab)
Key exclusion· 16
  • ✕Targetable EGFR mutation, ALK/ROS1 rearrangement, BRAF mutation, or NTRK fusion with available standard of care
  • ✕Symptomatic, neurologically unstable CNS metastasis or CNS disease requiring increased steroid dose
  • ✕Prior MET-directed therapy (except Phase Ib METex14 skipping patients)
  • ✕Other primary malignancies except non-melanoma skin cancer, in situ breast/cervical cancer, superficial bladder cancer, or other cancer curatively treated with ≥5 years disease-free

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04270591
NCT04270591Phase 2RecruitingUpdate OverdueUpdated 47mo ago · Completion was 32mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations

Haihe Biopharma Co., Ltd.·interventional·Posted Feb 17, 2020·Updated Aug 1, 2022

In Brief

A Phase 2 clinical trial evaluating Glumetinib for C-Met Exon 14 Mutation. Currently recruiting, targeting 183 participants across 44 sites in 3 countries.

Signals

Enrollment appears stalled

Detailed Summary

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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsC-Met Exon 14 Mutation
CountriesChina, Japan, United States
Collaborators--

Timeline

Phase 2RecruitingOverdue
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartJul 15, 2019
Primary CompletionOct 25, 2023
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.4 years ago

Interventions

Glumetinibdrug

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