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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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 III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) 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

NCT04853342•Allist Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

June 7, 2021

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2030

Last Updated

April 4, 2025

Enrollment

318

ESTIMATED participants

Conditions

Non-small Cell Lung Carcinoma

Interventions

Drug: Furmonertinib 80 mg

DRUG

Furmonertinib 80 mg placebo

DRUG

Contacts

Jianxing He, PHD

CONTACT

020-83062114 drjianxing.he@gmail.com

Wenhua Liang, PHD

CONTACT

020-83062114 liangwh1987@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

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