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NCT05987826Not yet recruiting

Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC

Furmonertinib Mesylate Neoadjuvant Treatment of Resectable Stage Ⅱ-ⅢB Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor(EGFR)Sensitive Mutation:a Prospective,Muliticenter,Open Label,Phase Ⅱ Single-arm Study
Shanghai Zhongshan HospitalPhase 2ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Furmonertinib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Zhongshan Hospital
Timeline & enrollment
Phase
Phase 2
Start date
Aug 01, 2023
End date
Dec 01, 2025
Enrollment
40 participants
Primary outcome

objective response rate(ORR)

Summary

EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer
 with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as
 postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on
 neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103,
 currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and
 gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR
 mutation-positive non-small-cell lung cancer, did not yield significantly positive objective
 remission rate (ORR) results.
 
 Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase
 inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib
 demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations
 and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of
 this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for
 resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and
 safety. Patinents are planned to be recruited from five centers in China. Eligible patients
 will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and
 safety of furmonnertinib neoadjuvant.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05987826
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05987826 through Pure Global AI's free database. This Phase 2 trial is sponsored by Shanghai Zhongshan Hospital and is currently Not yet recruiting. The study focuses on Non-Small Cell Lung Cancer. Target enrollment is 40 participants.

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