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

Sponsor
Allist Pharmaceuticals, Inc.
Study ID
NCT04958967
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 1, 2021
Status verified
Jul 2021
Primary completion
May 1, 2022
Completion
Aug 1, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treated subjects will receive Furmonertinib 240mg/day,
    treated subjects will receive Furmonertinib 240mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.
  • Experimental: treated subjects will receive Furmonertinib 160mg/day
    treated subjects will receive Furmonertinib 160 mg/day, QD, PO, under fasted state, until progressive disease, death or intolerability.

Primary Outcome Measure

ORR, objective response rate [ Time Frame: up to 12 months ]

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