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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04762459
Other study ID # YX-L-202105
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date August 1, 2021
Est. completion date May 2029

Study information

Verified date February 2021
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, open label, phase III study.


Description:

This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 606
Est. completion date May 2029
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: - Any patient who meets all of the following inclusion criteria will qualify for entry into the study: 1. Male or female, aged at least 18 years. 2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology. 3. Brain examination must be done prior to surgery as it is considered standard of care. 4. Patients must be classified post-operatively as Stage II-IIIA on the basis of pathologic criteria. 5. 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. 6. Providing paraffin embedded section(10-15sheets),wax blocks or fresh frozen tissues. 7. 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. 8. World Health Organization Performance Status of 0 to 1. 9. 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. 10. Male patients should be willing to use barrier contraception from screening to stopping study treatment for 3 months.(i.e., condoms). 11. For inclusion in study, patient must provide a written informed consent. 12. =10 weeks between surgery and randomization. Exclusion Criteria: - Any patient who meets any of the following exclusion criteria will not qualify for entry into the study: 1. Treatment with any of the following: 1. Pre-operative or post-operative or planned radiation therapy for the current lung cancer 2. Pre-operative (neo-adjuvant) platinum based or other chemotherapy 3. Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time 4. Any other anti-tumor treatment for lung cancer(Including proprietary Chinese patent medicine with anti-tumor effects and anti-tumor immunotherapy, etc.) 5. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug. 6. Treatment with an investigational drug within five half-lives of the compound or any of its related material. 7. 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.. 2. Patients who have had only segmentectomies or wedge resections 3. 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. 4. 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. 5. 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). 6. 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. 7. Any of the following cardiac criteria: 1. 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). 2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms). 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 9. Inadequate bone marrow reserve or organ function. 10. History of hypersensitivity to any active or inactive ingredient of Almonertinib, or to drugs with a similar chemical structure or class to Almonertinib. 11. Patients who are allergic to pemetrexed or any other ingredients in the preparation, cisplatin or other platinum-containing compounds. 12. Patients with contraindications of pemetrexed and cisplatin. 13. Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety. 14. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. 15. Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.

Study Design


Intervention

Drug:
Almonertinib
Almonertinib 110mg PO once daily
Pemetrexed
500 milligrams per square meter (mg/m²) Pemetrexed
Cisplatin
75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently

Locations

Country Name City State
China Cancer Hospital Chinese Academy of Medical Sciences Beijing
China Chinese Academy of Medical Science Beijing 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

Sponsors (3)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences GeneCast Biotechnology Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Incidence of Adverse Events (AEs) AEs graded by CTCAE version 4.0 From date of randomization until 28 days after treatment completion
Primary 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 Disease free survival (DFS) Defined as the proportion of patients alive and disease free at 2, 3 ,4and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis. 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 Overall Survival (OS) Defined as the time from the date of randomization until date of death due to any cause. Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 100 months
Secondary Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. From date of randomization until treatment completion or discontinuation, assessed up to 100 months
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