NCT06585644

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

Furmonertinib in Combination with Anlotinib and Chemotherapy As Neoadjuvant Treatment for Resectable, Stage II-III EGFR-Mutated Non-Small Cell Lung Cancer: a Single-Arm, Open-Label, Phase II Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Furmonertinib is a third-generation EGFR-TKI developed by Shanghai Allist Pharmaceuticals, capable of targeting both EGFR-sensitive mutations and the Thr790Met mutation. The FURLONG study demonstrated that, in Chinese patients with EGFR-mutant NSCLC, first-line treatment with furmonertinib showed superior PFS and better tolerability compared to the first-generation EGFR-TKI gefitinib, particularly in patients with central nervous system metastases. Anlotinib is a multi-target TKI developed by Chia Tai Tianqing Pharmaceutical, which can inhibit multiple kinases, including VEGFR, PDGFR, FGFR, and c-Kit, exhibiting anti-tumor angiogenesis and tumor growth inhibition effects. The FLALTER study showed that anlotinib combined with gefitinib significantly prolonged median PFS in treatment-naive metastatic EGFR-mutant NSCLC patients. Preliminary results from ongoing clinical trials indicate that the ORR of anlotinib combined with third-generation EGFR-TKIs in advanced NSCLC ranges from 65.20% to 96.15%. Compared to adjuvant therapy, neoadjuvant therapy for resectable NSCLC offers several potential benefits, including improved patient tolerance, early control of microscopic metastatic disease through systemic treatment, and the potential for less extensive surgical resection, leading to an increased rate of complete (R0) resection. So far, the exploration of EGFR-TKIs, including gefitinib, erlotinib, and osimertinib, in the field of neoadjuvant therapy has been undertaken. An open-label, single-arm Phase 2 study (NCT00188617) demonstrated that gefitinib is a safe and feasible option for unselected patients with Stage I NSCLC, with an ORR of 11%. Another single-arm Phase 2 study (NCT01833572) showed that neoadjuvant gefitinib is a feasible treatment for patients with Stage II-IIIA NSCLC harboring EGFR mutations, with an ORR of 54.5%, a MPR rate of 24.2%, and a median DFS of 33.5 months. The EMERGING-CTONG 1103 trial was the first randomized Phase 2 study comparing neoadjuvant erlotinib with chemotherapy in patients with locally advanced (Stage IIIA-N2) NSCLC with EGFR-sensitive mutations. The final results, with a median follow-up of 62.5 months, showed that the PFS in the neoadjuvant erlotinib group was significantly longer than in the chemotherapy group, although this did not translate into an OS benefit. Preliminary results from ongoing clinical trials with osimertinib suggest that this third-generation EGFR-TKI is generally safe and may be an effective neoadjuvant treatment option. This study aims to investigate the efficacy and safety of neoadjuvant furmonertinib combined with anlotinib and chemotherapy in resectable stage II-III EGFR-mutant NSCLC.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Furmonertinib in combination with Anrotinib and chemotherapy	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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-11-01
• Completion: 2030-06-01
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

1 site across 1 country: China