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Can a targeted pill keep lung cancer from returning?

NCT ID NCT04853342

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Suzhou, Jiangsu, 215000, China

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