Can a targeted pill keep lung cancer from returning?
NCT ID NCT04853342
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial is testing whether the drug furmonertinib can help prevent non-small cell lung cancer from coming back after surgery. The study enrolls adults with stage II-IIIA lung cancer that has specific EGFR mutations and who have had the tumor completely removed, with or without chemotherapy. Participants are randomly assigned to receive either furmonertinib or a placebo daily. The main goal is to see if the drug extends the time before the cancer returns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Furmonertinib (AST2818), an oral drug that targets EGFR mutations in lung cancer cells
- What this could lead to
- If successful, this could provide a new treatment option to help prevent lung cancer from returning after surgery in patients with EGFR-mutated non-small cell lung cancer.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. The drug may not improve disease-free survival or could cause side effects. It is only tested in a specific patient group with certain EGFR mutations.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 318 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2021
- Expected to finish
-
Jan 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Male or female, aged at least 18 years. * Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology. * MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. * Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria. * Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M. * Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for the tumor. * Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization. * World Health Organization Performance Status of 0 to 1. * Female patients should be using adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test prior to the first dose of the study drug; or female patients must have evidence of non-child-bearing potential. Exclusion Criteria: * Pre-operative or post-operative or planned radiation therapy for the current lung cancer * Pre-operative (neo-adjuvant) platinum-based or other chemotherapy * Any prior anticancer therapy * Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time * Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug * Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4 * Treatment with an investigational drug within five half-lives of the compound or any of its related material. * Patients who have had only segmentectomies or wedge resections * History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for \> 5 years following the end of treatment. * Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy. * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291. * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG Machine-derived QTc value. * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. * Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * Inadequate bone marrow reserve or organ function.
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 carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Seeing Cancer's hidden markers: a new PET tracer could reveal who responds to targeted therapy
- Lab-Made immune protein takes on advanced cancers in first human test
- Experimental combo for lung cancer shows promise but study cut short
- New study tracks how well a targeted lung cancer drug works in everyday clinics
- New 4D scan could sharpen lung cancer radiation
- Laser and Light-Sensitive drug shrink lung tumors in early trial