A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT06585644
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Furmonertinib in combination with Anrotinib and chemotherapy — DRUG
    The enrolled patients are planned to receive preoperative treatment with a combination of furmonertinib and anrotinib, along with platinum-based doublet chemotherapy. Three weeks after the completion of this treatment, they will undergo curative lung lobe resection and systemic lymph node dissection. Postoperatively, they will continue taking furmonertinib for one year. In case of disease progression, they will be switched to comprehensive therapy.

Study Details

Evaluate the efficacy and safety of neoadjuvant furmonertinib combined with anlotinib and chemotherapy in patients with resectable stage II-III EGFR mutation-positive non-small cell lung cancer.

Key Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Nov 1, 2025
Completion
Jun 1, 2030

Study Design

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

Arms

  • Experimental: Treatment group
    Furmonertinib in combination with anlotinib and chemotherapy as a neoadjuvant treatment regimen. The enrolled patients will take furmonertinib, with a dose of 80mg/d, from day 1 to day 21, q3w/cycle; and anrotinib, with a dose of 12mg/d, from day 1 to day 14, q3w/cycle. They will receive furmonertinib and anrotinib treatment for 3 cycles, and combined platinum-based chemotherapy for 4 cycles. CT assessment (RECIST1.1) will be conducted within 3 weeks after the completion of treatment. All patients will undergo radical lung lobectomy and systemic lymph node dissection 3 weeks after the end of treatment. Patients who undergo surgery (CR+PR+SD) will take furmonertinib at a dose of 80mg/d for 1 year. PD patients will be transferred to the oncology or radiation department for comprehensive treatment.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 3 Weeks ]

Central Contacts

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