Furmonertinib Monotherapy and Combination Therapy in Advanced EGFR Mutant NSCLC With Uncleared ctDNA

NCT05334277 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2022-08-31

No results posted yet for this study

Summary

EGFR mutation positive advanced NSCLC patients with uncleared ctDNA have poor prognosis, whether they can benefit from combination therapy has not been reported. This study aims to investigate the efficacy and safety of combination therapy compared with furmonertinib monotherapy in advanced EGFR mutant NSCLC with uncleared circulating tumor cell DNA.

Conditions

Interventions

DRUG

Furmonertinib

Furmonertinib 80mg QD

DRUG

Furmonertinib

Furmonertinib 80mg QD

DRUG

Furmonertinib/Pemetrexed/Carboplatin

Furmonertinib 80mg daily + Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) every 3 weeks.

DRUG

Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab

Furmonertinib 80mg daily + Pemetrexed (500 mg/m2) plus carboplatin (AUC 5) plus bevacizumab (7.5mg/kg) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed (500 mg/m2) with bevacizumab (7.5mg/kg) maintenance every 3 weeks.

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • GeneCast Biotechnology Co., Ltd.

    collaborator INDUSTRY
  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2025-02-28
Completion
2028-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05334277 on ClinicalTrials.gov