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

Allist Pharmaceuticals, Inc.1 site in 1 country318 target enrollmentJune 7, 2021

ConditionsNon-small Cell Lung Carcinoma

InterventionsFurmonertinib 80 mg placebo

DrugsDrug: Furmonertinib 80 mg Furmonertinib 80 mg placebo

Overview

Phase: Phase 3
Intervention: Furmonertinib 80 mg placebo
Conditions: Non-small Cell Lung Carcinoma
Sponsor: Allist Pharmaceuticals, Inc.
Enrollment: 318
Locations: 1
Primary Endpoint: DFS
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 7, 2021

End Date

January 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allist Pharmaceuticals, Inc.

Responsible Party

Sponsor

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 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
•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.

Arms & Interventions

Placebo Furmonertinib

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

Intervention: Furmonertinib 80 mg placebo

Outcomes

Primary Outcomes

DFS

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]

Disease free survival

Secondary Outcomes

Disease free survival (DFS) rate(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])
Overall Survival (OS)(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])
Overall Survival rate at 5 years(Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years])