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

NCT04853342 | Recruiting Phase 3

• 1 other identifier: ALSC010AST2818
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival

  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 (3)

• 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]

Study Arms (2)

Furmonertinib

EXPERIMENTAL

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

Drug: Drug: Furmonertinib 80 mg

Placebo Furmonertinib

PLACEBO COMPARATOR

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

Drug: Furmonertinib 80 mg placebo

Interventions

Drug: Furmonertinib 80 mg DRUG

The initial dose of Furmonertinib 80 mg once daily

Furmonertinib

Furmonertinib 80 mg placebo DRUG

The initial dose of Furmonertinib 80 mg once daily

Placebo Furmonertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianxing He, PHD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He, PHD

CONTACT

020-83062114; drjianxing.he@gmail.com

Wenhua Liang, PHD

CONTACT

020-83062114; liangwh1987@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 21, 2021
• Study Start: June 7, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

CN (1)