Bevacizumab Combined With Double Doses of Icotinib in Advanced NSCLC Patients With EGFR L858R Mutation

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05263947
Phase
PHASE2
Status
Completed

Conditions

  • Bevacizumab
  • Carcinoma, Non-Small-Cell Lung
  • EGFR L858R
  • Tyrosine Kinase Inhibitor

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    15 mg/kg, intravenous infusion, every three weeks
  • Icotinib — DRUG
    Oral 250 mg, three times per day

Study Details

This is a prospective, single-arm, single-center, phase II trial designed to evaluate the efficacy and safety of bevacizumab combined with a double dose of icotinib as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) harboring an EGFR Exon 21 L858R mutation. Patients will receive bevacizumab and icotinib (250 mg, administered orally three times per day ) until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity profile. The hypothesis is that the combination therapy will provide improved outcomes for this patient population, which typically has a poorer response to standard EGFR-TKI therapy.

Key Dates

First listed
Mar 3, 2022
Start date
Jan 30, 2022
Status verified
Jan 2023
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab Combined with Icotinib
    Participants receive bevacizumab 15 mg/kg by intravenous infusion once every 3 weeks, and oral icotinib 250 mg three times per day until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 18 months ]

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