Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment

NCT04882345 | Unknown Phase 2

• 1 other identifier: YX-L-202109
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of Almonertinib treatment in patients with EGFR mutation positive and advanced non-small cell lung cancer (NSCLC) who are intolerant to the safety of osimertinib treatment.

Conditions

Lung Cancer; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Assess the safety of Almonertinib: Number of AEs/SAEs

  Number of adverse events (AEs)/serious adverse events (SAEs)

  Continuously throughout the study until 28 days after Termination of the treatment

Secondary Outcomes (6)

• Assess the anti-tumor activity: Progression Free Survival (PFS)

  From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months

• Assess the anti-tumor activity: Objective response rate (ORR)

  From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months

• Assess the anti-tumor activity: Disease control rate (DCR)

  From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months

• Assess the anti-tumor activity: Duration of response (DoR)

  the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.

• Assess the anti-tumor activity: Overall survival (OS)

  an average of 4 years

Study Arms (1)

Almonertinib group

EXPERIMENTAL

Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Drug: Almonertinib

Interventions

Almonertinib DRUG

Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Also known as: HS-10296

Almonertinib group

Eligibility Criteria

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

You may qualify if:

• Over 18 years old (including 18 years old) and under 75 years old (including 75 years old)
• Histologically or cytologically diagnosed as locally advanced or metastatic NSCLC.
• The CTCAE ≥ grade 3 AE related to osimertinib treatment in previous treatment with osimertinib, or platelet count \<75×109 / L (≥CTCAE grade 2), white blood cell count \<3×109 / L (≥ CTCAE grade 2), total bilirubin\> 1.5×ULN (≥CTCAE grade 2), transaminase (ALT/AST)\>3.0×ULN (≥CTCAE grade 2), and the toxic reaction has been alleviated or restored to ≤CTCAE grade 1 patient.
• Tumor tissue samples diagnosed as locally advanced or metastatic NSCLC are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). If the tumor tissue is accessible, it is recommended to send the tumor tissue for examination; if the tumor tissue is not accessible or the patient cannot accept a tissue biopsy, a blood sample is also acceptable.
• The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1, and it has not deteriorated in the previous 2 weeks, and the minimum expected survival is 12 weeks.
• The patient has at least one tumor lesion that can be accurately measured at baseline, and the longest diameter at baseline is ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm). The selected measurement method is suitable for accurate repeat measurement, which can be computed tomography (CT) or magnetic resonance scan (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and a baseline assessment of the tumor lesion should be performed at least 14 days after the diagnostic biopsy.
• 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 is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
• Postmenopausal is defined as amenorrhea for at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped.
• For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered post-menopausal.
• Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral fallopian tube ligation.
• Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment.
• The subjects themselves participated voluntarily and signed an informed consent form in writing.

You may not qualify if:

• Have received any of the following treatments:
• Have previously received any EGFR tyrosine kinase inhibitor treatment except osimertinib;
• The patient had undergone major surgery within 4 weeks before the first administration;
• Accept other test drugs, and within 5 half-lives;
• Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers, or drugs with a narrow therapeutic window that are CYP3A4 sensitive substrates have been used.
• Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment.
• As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection. No need to check for chronic diseases.
• Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drugs or having undergone extensive bowel resection may affect the full absorption of Almonertinib.
• A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of interstitial pneumonia requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
• Meet any of the following cardiac examination results:
• The average corrected QT interval (QTc)\> 470 msec obtained from 3 ECG examinations in the resting state, the Fridericia formula is used for QT interval correction (QTcF);
• Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block, and PR between Period\> 250 msec);
• There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
• Left ventricular ejection fraction (LVEF) ≤50%.
• Insufficient bone marrow reserve or organ function, reaching the following laboratory limits:

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongsheng Li

  The Affiliated Cancer Hospital of Chongqing University

  PRINCIPAL INVESTIGATOR

• Jianying Zhou

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xiuyu Cai

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yueyin Pan

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

• Wenxiu Yao

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

• Chun Huang

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Minglei Zhuo

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Conghua Xie

  Wuhan University

  PRINCIPAL INVESTIGATOR

• Meiqi Shi

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

• Qibin Song

  Hubei Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shun Lu, doctor

CONTACT

13601813062; shun_lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: July 15, 2021
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share