Actively Recruiting
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
Led by Allist Pharmaceuticals, Inc. · Updated on 2025-04-04
318
Participants Needed
1
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged at least 18 years
- Histologically confirmed primary non-small cell lung cancer (NSCLC) with predominantly non-squamous histology
- MRI or CT scan of the brain done before surgery
- Post-operative classification as Stage IB, II, or IIIA based on pathology
- Central lab confirmation of tumor harboring common EGFR mutations (Ex19del, L858R), alone or with other EGFR mutations including T790M
- Complete surgical removal of the primary NSCLC with negative margins
- Complete recovery from surgery and any post-operative therapy at randomization
- WHO Performance Status of 0 to 1
- Female patients must use adequate contraception, not be breastfeeding, have a negative pregnancy test before first dose, or have non-child-bearing potential
You will not qualify if you...
- Pre-operative, post-operative, or planned radiation therapy for current lung cancer
- Pre-operative (neoadjuvant) chemotherapy
- Any prior anticancer therapy
- Previous treatment with neoadjuvant or adjuvant EGFR-TKI
- Major surgery within 4 weeks before first study drug dose
- Use of medications or supplements that strongly induce cytochrome P450 (CYP) 3A4
- Treatment with investigational drug within five half-lives
- Patients who had only segmentectomies or wedge resections
- History of other malignancies except certain treated skin and in-situ cancers or solid tumors disease-free for over 5 years
- Unresolved toxicities from prior therapy above CTCAE Grade 1 except alopecia and Grade 2 platinum-related neuropathy
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding, or infections like hepatitis B, C, or HIV
- Severe gastrointestinal diseases or inability to swallow study drug
- Cardiac abnormalities including QTc >470 msec, rhythm or conduction issues, or risk factors for arrhythmia
- Past history of interstitial lung disease or radiation pneumonitis requiring steroid treatment
- Inadequate bone marrow or organ function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
J
Jianxing He, PHD
CONTACT
W
Wenhua Liang, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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