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Clinical Trials in China / NCT04762459
Enrolling by invitation Phase 3

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

NCT04762459 · tracked via the Priya Life Science China tracker
Sponsor
Chinese Academy of Medical Sciences
Phase
Phase 3
Started
2021-08-01
Last updated
2022-02-24

Condition(s) studied

Non-small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

AlmonertinibPemetrexedCisplatin

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Chinese Academy of Medical Science Beijing Beijing Municipality
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04762459 on ClinicalTrials.gov ↗ ← All trials in China