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Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation

NCT04858958 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-19

No results posted yet for this study

Summary

This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation.

The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability.

The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).

In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Conditions

Interventions

DRUG

Furmonertinib 160mg

randomized to 160mg QD

DRUG

Furmonertinib 240mg

randomized to 240mg QD

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Baohui C Han, PHd · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2024-12-05
Completion
2026-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858958 on ClinicalTrials.gov