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NCT04270591 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of C-Met Exon 14 Mutation, sponsored by Haihe Biopharma Co..

Recruiting
Registry status
Phase 1
Development phase
183
Enrollment target
20
Study locations

NCT04270591: Recruiting Phase 1 study of C-Met Exon 14 Mutation, sponsored by Haihe Biopharma Co..

NCT04270591 is a Phase 1 study of C-Met Exon 14 Mutation that is actively recruiting participants, run by Haihe Biopharma Co.. The registered enrollment target is 183 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (205% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04270591, a Phase 1 study of C-Met Exon 14 Mutation, is actively recruiting participants, sponsored by Haihe Biopharma Co..

RECRUITING
Registry status
Phase 1
Development phase
183 participants
Enrollment target
20
Study locations

Study 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)

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Glumetinib

Study Locations (20)

Beijing Municipality

  • Beijing Cancer Hospital - Beijing
  • Beijing Cancer Hospita - Beijing
  • Peking Union Medical College Hospital - Beijing

Kentucky

  • Norton Cancer Institute - Louisville
  • The Oncology Institute of Hope & Innovation - Louisville

Anhui

  • Anhui Province Hospital - Hefei
  • The Chest Hospital of Anhui Province - Hefei

Hubei

  • Hubei Cancer Hospital - Wuhan
  • Wuhan Union Hospital - Wuhan

Jiangsu

  • Jiangsu Cancer Hospital - Nanjing
  • Jiangsu Province People's Hospital - Nanjing

Fujian

  • Union Medical College Hospital Affiliated to Fujian Medical University - Fuzhou

Guangdong

  • The First Affiliated Hospital of Guangzhou Medical University - Guangzhou

Guangxi

  • Cancer Hospital Affiliated to Guangxi Medical University - Nanning

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2019-07-15
Est. Completion 2023-12-30
Phase Phase 1
Haihe Biopharma Co.

4 total trials

What NCT04270591 shows while recruiting

NCT04270591 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (205% higher).

The record links to 1 condition, with C-Met Exon 14 Mutation appearing as the primary indexed condition, and to 1 intervention - of which Glumetinib is the first listed.

NCT04270591 names 20 study sites across 14 states, led by Beijing Municipality, Kentucky, Anhui.

Frequently Asked Questions

What is clinical trial NCT04270591 about?

NCT04270591 is a clinical study titled "Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer". 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)

What is the current status of trial NCT04270591?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 183 participants. The study started on 2019-07-15. Estimated completion is 2023-12-30.

What conditions does trial NCT04270591 study?

This clinical trial studies the following conditions: C-Met Exon 14 Mutation.

What interventions are being tested in trial NCT04270591?

The interventions under investigation include: Glumetinib (DRUG).

Who is sponsoring clinical trial NCT04270591?

This trial is sponsored by Haihe Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04270591 being conducted?

This trial has 20 study locations across Kentucky, Anhui, Beijing Municipality, Fujian, Guangdong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04270591's enrollment target sits among peer trials

183 298th of 2000 higher than 1,702 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04270591, the US trial registry maintained by the National Library of Medicine. NCT04270591 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.