Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585644
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
A Clinical Trial of Furmonertinib Combination Therapy As Neoadjuvant Treatment in Resectable EGFR-Mutated NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 6520 to 9615 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 545 a MPR rate of 242 and a median DFS of 335 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 625 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None