Tests furmonertinib before surgery in lung cancer with EGFR mutations
Tests furmonertinib before surgery in adults with operable EGFR-mutant lung cancer.
Key facts
- Who runs it
- Shanghai Zhongshan Hospital
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 40 people, planned
- Started
- 19 Sept 2023
- Expected to end
- Dec 2029
- Type of study
- Interventional
- Treatments tested
- Furmonertinib
- Record updated
- 24 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage II-IIIB non-small cell lung cancer that can be removed by surgery and has an EGFR mutation. They have had no cancer treatment yet and will take furmonertinib for 8 weeks before surgery.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, stage II-IIIB, expected to be removable by surgery. Stage IIIB only if cT3N2M0. At least one tumour that can be measured (longest axis 10mm or more). Good daily function (ECOG 0 to 1).
- Earlier treatment
- No earlier cancer treatment of any kind.
- Biomarker or test result
- EGFR mutation: exon 19 deletion or exon 21 L858R, with or without other EGFR mutations.
Main reasons for not taking part
- Two or more separate primary lung cancers
- Another cancer, unless fully removed with no return for 5 years or more
- History of interstitial lung disease
- Pregnant or breastfeeding
- Severe or uncontrolled illness, such as heart failure, uncontrolled diabetes or active HBV/HCV/HIV infection
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 1）Provide informed consent prior to any study specific procedures
- 2）at least 18 years of age，not more than 75 years
- 3）Histology or cytology diagnose of non-small cell lung cancer within 60 days
- 4）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
- 5）Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients
- 6）According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
- 7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- 8）Without prior anti-tumor treatment
- 9) Withe adequate organ function of hematology, liver and kidney
- 10）Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age
Who cannot take part
- 2）Any prior anti-tumor treatment
- 6）Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment
- 3）With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- 4）History of interstitial lung disease or with relative risk factors
- 5）Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
- 7）With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
- 9）psychopath and/or mental illness
- 10）Pre-existing or coexisting bleeding disorders
- 12）Allergic to study drugs or any component
- 13）Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
- 8）Prolongation of ECG QTc or with relative risk factors
- 1）Dual or multiple primary NSCLC
- 11）Women with pregnancy or breastfeeding
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- 180 Fenglin RoadShanghai, ChinaContact: di geTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Furmonertinib (AST2818) 80mg QD groupTreatment being tested
All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.
Treatment: Furmonertinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests furmonertinib before surgery in lung cancer with EGFR mutationsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05987826, who can take part
- Record updated
- 24 August 2026