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High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC

NCT07182708 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.

Conditions

  • NSCLC (Non-small Cell Lung Cancer)
  • EGFR Activating Mutation
  • Resectable Lung Non-Small Cell Carcinoma

Interventions

DRUG

Firmonertinib Mesilate Tablets

Firmonertinib Mesilate Oral administration 160 mg once daily for 3 months before surgery. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. After surgery, the treatment plan was determined by the researchers, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.

DRUG

Bevacizumab injection

Bevacizumab injection (intravenous infusion, 7.5 mg/kg) administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2029-12-30
Completion
2030-06-30

Countries

  • China

Study Locations

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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 NCT07182708 on ClinicalTrials.gov