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

NCT06585644 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: STAR 008
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (NSCLC)

Keywords

Neoadjuvant; EGFR-mutant non-small-cell lung cancer; Furmonertinib; Anlotinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  According to RECIST 1.1, objective response rate (ORR) refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that response for a specific duration, including those with complete response (CR) and partial response (PR). Complete response is defined as the complete disappearance of all target lesions, with the shortest diameter of any pathological lymph nodes (including both target and non-target nodes) shrinking to less than 10mm. Partial response is characterized by at least a 30% reduction in the diameter of the target lesion compared to baseline levels. In this study, ORR is defined as the proportion of patients who completed neoadjuvant therapy before surgery and achieved either CR or PR based on CT evaluation three weeks after treatment.

  3 Weeks

Secondary Outcomes (7)

• Major Pathological Response

  3 Weeks

• Complete Pathological Response

  3 Weeks

• R0 Resection Rate

  3 Weeks

• Disease Free Survival

  5 years

• Overall Survival

  5 years

Study Arms (1)

Treatment group

EXPERIMENTAL

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.

Drug: Furmonertinib in combination with Anrotinib and chemotherapy

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.

Also known as: Treatment regimen of Furmonertinib in combination with Anrotinib and chemotherapy

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Haifeng Wang, MD

CONTACT

18758363835; 3891712761@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)