Study of Osimertinib+Bevacizumab+Chemotherapy for EGFR+ Advanced Non-Small Cell Lung Cancer With Concurrent Mutations

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT05507606
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    osimertinib 80mg/d
  • Bevacizumab Biosimilar IBI305 — DRUG
    Bevacizumab, 7.5mg/kg d1; was discontinued after 2 years
  • Carboplatin — DRUG
    Carboplatin AUC5, d1; was stopped after 4 cycles
  • Pemetrexed — DRUG
    Pemetrexed, 500mg/m2, d1;Q3W/cycle; was discontinued after 2 years

Study Details

This is a single-center, open-label, phase I clinical trial aimed to evaluate the efficacy and safety of Osimertinib+Bevacizumab+Carboplatin and Pemetrexed for Untreated Patients With EGFR Mutation Advanced Non-squamous Non-Small Cell Lung Cancer With Concomitant Mutations.

Key Dates

Start date
Aug 1, 2021
Status verified
Aug 2022
Primary completion
Aug 1, 2023
Completion
Aug 1, 2024

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib+Bevacizumab+Carboplatin and Pemetrexed
    Bevacizumab, 7.5mg/kg, d1; Pemetrexed, 500mg/m2, d1; Carboplatin AUC5, d1; Osimertinib 80mg/d , d1-21; Q3W/cycle induction therapy for 4 cycle. Then Carboplatin was stopped after 4 cycles, and Osimertinib combined with Bevacizumab and Pemetrexed were given for maintenance treatment every 3 weeks for 2 years. After that, the maintenance treatment of Osimertinib was continued.

Primary Outcome Measure

ORR [ Time Frame: 2 years ]

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