Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection
APEX
1 other identifier
interventional
606
1 country
34
Brief Summary
This is a multicenter, randomized, open label, phase III study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2021
Longer than P75 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
ExpectedFebruary 24, 2022
February 1, 2021
4.8 years
February 10, 2021
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary Outcomes (3)
Disease free survival (DFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 100 months
Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey
From date of randomization until treatment completion or discontinuation, assessed up to 100 months
Other Outcomes (1)
Incidence of Adverse Events (AEs)
From date of randomization until 28 days after treatment completion
Study Arms (3)
Almonertinib
ACTIVE COMPARATORDrug: Almonertinib 110 mg A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
Almonertinib/Pemetrexed/Cisplatin
EXPERIMENTALDrug: Almonertinib 110 mg Drug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
Pemetrexed/Cisplatin
ACTIVE COMPARATORDrug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. If disease progresses during the treatment period and conditions required for the cross-treatment are met according to the assessment process, the patient can start to receive the open cross-treatment of Almonertinib. The overall treatment last for 3 years.
Interventions
500 milligrams per square meter (mg/m²) Pemetrexed
75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently
Eligibility Criteria
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.
- Brain examination must be done prior to surgery as it is considered standard of care.
- Patients must be classified post-operatively as Stage II-IIIA on the basis of pathologic criteria.
- Confirmation by the central laboratory that the tumour harbours 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.
- Providing paraffin embedded section(10-15sheets),wax blocks or fresh frozen tissues.
- 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 tumour.
- World Health Organization Performance Status of 0 to 1.
- Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test was negative.
- Male patients should be willing to use barrier contraception from screening to stopping study treatment for 3 months.(i.e., condoms).
- ≤10 weeks between surgery and randomization.
You may not qualify if:
- Treatment with any of the following:
- Pre-operative or post-operative or planned radiation therapy for the current lung cancer
- Pre-operative (neo-adjuvant) platinum based or other chemotherapy
- Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
- Any other anti-tumor treatment for lung cancer(Including proprietary Chinese patent medicine with anti-tumor effects and anti-tumor immunotherapy, etc.)
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Medications that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug..
- 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 tumours 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 Almonertinib.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- Jiangsu Hansoh Pharmaceutical Co., Ltd.collaborator
- GeneCast Biotechnology Co., Ltd.collaborator
Study Sites (34)
Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
Sichuan Cancer Hospital
Chendu, China
Sichuan Provincial People's Hospital
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Consonancy Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University School Of Medicine
Hangzhou, China
The First People's Hospital of Yunnan Province
Kunming, China
Yunnan Cancer Hospital
Kunming, China
JiangXi Cancer Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Provincial People's Hospital
Nanjing, China
Ningbo Medical Center Li Huili Hospital
Ningbo, China
Qingdao Municipal Hospital
Qingdao, China
Fudan University Shanghai Cancer Center
Shanghai, China
ShangHai Chest Hospital ShangHai JiaoTong University
Shanghai, China
ShangHai Pulmonary Hospital
Shanghai, China
Liaoning Cancer Hospital
Shenyang, China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen, China
Hebei Cancer Hospital
Shijiazhuang, China
West China Hospital，Sichuan University
Sichuan, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Thoracic Surgery Department Of The ShanXi Provincial Cancer Hospital
Taiyuan, China
Tianjin Chest Hospital
Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, China
Weifang People's Hospital
Weifang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Wuhan Union Hospital Of China
Wuhan, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 21, 2021
Study Start
August 1, 2021
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2029
Last Updated
February 24, 2022
Record last verified: 2021-02