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Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC - Trial NCT05987826

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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NCT05987826
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.govNCT05987826
View on ClinicalTrials.gov
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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

Study Focus

Furmonertinib

Interventional

drug

Sponsor & Location

Shanghai Zhongshan Hospital

Timeline & Enrollment

Phase 2

Aug 01, 2023

Dec 01, 2025

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 lung
Malignant neoplasm: Lower lobe, bronchus or lung
Malignant neoplasm: Middle lobe, bronchus or lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm of bronchus and lung

Data Source

ClinicalTrials.gov

NCT05987826

Non-Device Trial