Can a targeted pill shrink lung tumors before surgery?
NCT ID NCT05987826
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether giving the targeted drug furmonertinib for 8 weeks before surgery can shrink tumors in people with stage II-IIIB non-small cell lung cancer that has EGFR-sensitive mutations. The study enrolls about 40 adults who are eligible for surgery. The goal is to see how well the drug works at reducing tumor size and whether it leads to a major or complete pathological response in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- furmonertinib (a third-generation EGFR tyrosine kinase inhibitor)
- What this could lead to
- If successful, this could establish furmonertinib as a pre-surgery treatment to shrink tumors, potentially making surgery more effective and improving long-term outcomes for people with EGFR-mutant lung cancer.
- What could go wrong
- This is a small, early-phase study (40 people) without a comparison group, so results may not be conclusive. The drug may cause side effects, and not all tumors may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2023
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 1)Dual or multiple primary NSCLC * 2)Any prior anti-tumor treatment * 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 * 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 * 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 * 8)Prolongation of ECG QTc or with relative risk factors * 9)psychopath and/or mental illness * 10)Pre-existing or coexisting bleeding disorders * 11)Women with pregnancy or breastfeeding * 12)Allergic to study drugs or any component * 13)Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non small cell lung cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
180 Fenglin Road
RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink advanced solid tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?
- Can a new drug shrink advanced solid tumors?
- Can a less extensive lung cancer surgery be just as effective?