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RecruitingNCT04853342FORWARDUpdated Aug 13, 2026

To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

A Phase 3 interventional study of Drug: Furmonertinib 80 mg and Furmonertinib 80 mg placebo in Non-small Cell Lung Carcinoma, sponsored by Allist Pharmaceuticals, Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Allist Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.

02

Conditions studied

  • Non-small Cell Lung Carcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's planned enrollment of 318 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Allist Pharmaceuticals, Inc. is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female, aged at least 18 years.
  • 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 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-.

Exclusion criteria

Exclusion Criteria:

  • Pre-operative or post-operative or planned radiation therapy for the current lung cancer
  • Pre-operative () 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 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 , 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 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 , , and (HIV).
  • 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 interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic Machine-derived QTc value.
  • Any 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 treatment, or any evidence of clinically active ILD.
  • Inadequate bone marrow reserve or organ function.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
318 participants (estimated)

Study arms

  • Experimental
    Furmonertinib

    Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.

    Drug: Drug: Furmonertinib 80 mg

  • Placebo comparator
    Placebo Furmonertinib

    Matching placebo for Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.

    Drug: Furmonertinib 80 mg placebo

Interventions

  • The initial dose of Furmonertinib 80 mg once daily

  • DrugFurmonertinib 80 mg placebo

    The initial dose of Furmonertinib 80 mg once daily

06

What researchers measure

Primary outcomes

  1. DFS

    Disease free survival

    Time frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence). Estimated median time to event of 60 months for those treatment) [ Time Frame: Up to 5 years]

Secondary outcomes

  1. Disease free survival (DFS) rate

    Disease free survival (DFS) rate at 2, 3 and 5 years

    Time frame: Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence)Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]

  2. Overall Survival (OS)

    Defined as the time from the date of randomization until date of death due to any cause

    Time frame: Time Frame: From date of randomization until date of death due to any cause Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]

  3. Overall Survival rate at 5 years

    Defined as the proportion of patients alive at 5 years, estimated from a Kaplan Meier plot of OS at the time of the primary analysis

    Time frame: Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04853342
Responsible party
Sponsor
First posted
Apr 21, 2021
Start date
Jun 7, 2021
Primary completion
Dec 2026 (estimated)
Completion
Jan 2030 (estimated)
Last update
Aug 13, 2026

Study contacts

Jianxing He, PHD
Contact
drjianxing.he@gmail.com
020-83062114
Wenhua Liang, PHD
Contact
liangwh1987@163.com
020-83062114
Jianxing He, PHD
principal investigator · The First Affiliated Hospital of Guangzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Aflutinib

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