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

Sponsor
Sun Yat-sen University
Study ID
NCT05334277
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Furmonertinib — DRUG
    Furmonertinib 80mg QD
  • Furmonertinib — DRUG
    Furmonertinib 80mg QD
  • Furmonertinib/Pemetrexed/Carboplatin — DRUG
    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.
  • Furmonertinib/Pemetrexed/Carboplatin/Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 6, 2022
Status verified
Aug 2022
Primary completion
Feb 28, 2025
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: Group A: Furmonertinib 80mg QD
    Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
  • Experimental: Group B1: Furmonertinib 80mg QD
    Furmonertinib (AST2818) 80mg QD. All patients enrolled into this group will receive furmonertinib 80mg daily.
  • Experimental: Group B2: Furmonertinib plus chemotherapy
    Furmonertinib 80 mg QD and platinum-based chemotherapy All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with 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.
  • Experimental: Group B3: Furmonertinib plus chemotherapy and bevacizumab
    Furmonertinib 80 mg QD plus platinum-based chemotherapy and bevacizumab All patients enrolled into this group will receive furmonertinib 80 mg daily, in combination with 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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 34 months after the first patient begin study treatment ]

Central Contacts

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