NCT05987826RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 19 Sept 2023
- Primary completion date
- Aug 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05987826
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 19 Sept 2023 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 8）Prolongation of ECG QTc or with relative risk factors
Other
- 1）Dual or multiple primary NSCLC
- 11）Women with pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 180 Fenglin Road Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.