High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI

Sponsor
Jialei Wang
Study ID
NCT06652048
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib 160mg QD — DRUG
    All patients enrolled into this group will receive furmonertinib 160mg p.o qd.
  • Furmonertinib 240mg QD — DRUG
    All patients enrolled into this group will receive furmonertinib 240mg p.o qd.
  • Furmonertinib 160mg QD plus Chemotherapy — DRUG
    All patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\]

Study Details

This is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o qd or 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\].Patients will be followed up every 2 cycles during the first half year , and every 3 cycles after the first half year.Treatment was continued until disease progression,intolerable toxic effects, investigator decision, patient withdrawal of consent, or death, whichever occurred first.

Key Dates

Start date
Oct 1, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Furmonertinib 160mg QD
    All patients enrolled into this group will receive furmonertinib 160mg p.o qd.
  • Experimental: Furmonertinib 240mg QD
    All patients enrolled into this group will receive furmonertinib 240mg p.o qd.
  • Experimental: Furmonertinib 160mg QD plus Chemotherapy
    All patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\]

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 2 years ]

Central Contacts

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