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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07182708
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

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

Interventions

  • Firmonertinib Mesilate Tablets — DRUG
    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.
  • Bevacizumab injection — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 19, 2025
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Dec 30, 2029
Completion
Jun 30, 2030

Study Design

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

Arms

  • Experimental: Neoadjuvant therapy

Primary Outcome Measure

pathological Complete Response(pCR) rate [ Time Frame: Within 24 hours after surgical resection ]

Central Contacts

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