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
Recruiting
Phase 3Interventional Study
Non-small Cell Lung Carcinoma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
318 (estimated)
Sponsor
Allist Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for patients with a specific type of lung cancer who have had their tumors completely removed. Participants will receive either the medication Furmonertinib or a placebo to see how well it works and its safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with non-small cell lung cancer.
I have had complete removal of my lung tumor.
I have specific mutations in my tumor known to respond to EGFR drugs.
I have fully recovered from my surgery.
I have a performance status of 0 or 1.
I am not pregnant and am using effective birth control if I can become pregnant.
You may not be able to join if
I have received radiation therapy for my lung cancer.
I have had prior cancer treatments for this lung cancer.
I had major surgery within 4 weeks of the study.
I have severe or uncontrolled health issues.
I have a history of lung disease that needs treatment.
I have unexplained sudden death in my family under 40.
I have had certain heart rhythm problems.
I have taken certain medications that affect liver enzymes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 c…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 c…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.