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Phase Ib Study of FURMONERTINIB in Patients with NSCLC Having Exon 20 Insertion Mutation

NCT04958967 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-03-14

No results posted yet for this study

Summary

This is a phase 1 multi-center clinical study. To explore the 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 20subjects, including 20 treated patients aThe subjects will receive Furmonertinib Mesilate 240 mg/day or 160mg/day until disease progression, death or intolerability.

The primary endpoint is Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC); the secondary study endpoints include ORR（ Assessed by the Investigator），DCR，DOR，DpR，PFS，OS，CNS ORR（ Assessed by the Independent Review Committee） In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Conditions

Interventions

DRUG

Furmonertinib 240mg

treated subjects will receive Furmonertinib 240mg/day

DRUG

Furmonertinib 160mg

treated subjects will receive Furmonertinib 160mg/day

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

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
2021-10-01
Primary Completion
2022-05-01
Completion
2022-08-01

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 NCT04958967 on ClinicalTrials.gov