- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04853342
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 (FORWARD)
April 19, 2021 updated by: Allist Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
318
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianxing He, PHD
- Phone Number: 020-83062114
- Email: drjianxing.he@gmail.com
Study Contact Backup
- Name: Wenhua Liang, PHD
- Phone Number: 020-83062114
- Email: liangwh1987@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Furmonertinib
Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.
|
The initial dose of Furmonertinib 80 mg once daily
|
Placebo Comparator: Placebo Furmonertinib
Matching placebo for Furmonertinib (80 mg orally, once daily), in accordance with the randomization schedule.
|
The initial dose of Furmonertinib 80 mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival (DFS) rate
Time Frame: 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 (DFS) rate at 2, 3 and 5 years
|
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: 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]
|
Defined as the time from the date of randomization until date of death due to any cause
|
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: Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]
|
Defined as the proportion of patients alive at 5 years, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
|
Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianxing He, PHD, The First Affiliated Hospital of Guangzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 17, 2021
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
April 12, 2021
First Submitted That Met QC Criteria
April 19, 2021
First Posted (Actual)
April 21, 2021
Study Record Updates
Last Update Posted (Actual)
April 21, 2021
Last Update Submitted That Met QC Criteria
April 19, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALSC010AST2818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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