Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer

Lung Cancer Non-small Cell Stage IV Clinical Trial

Official title:

Phase II Clinical Study of Almonertinib in Combination With Lastet in the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463171
• Other study ID #: 2024LY0323
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jianing Chen
• Phone: 18916469896
• Email: johnny042018[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is: Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer in First-line Therapy. Participants will be treated with a combination of Aumolertinib and Lastet.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior to the implementation of any trial-related procedures, written informed consent must be obtained.
• Age =18 years.
• Patients with locally advanced (Stage III B/III C), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC) confirmed histologically or cytologically, who are ineligible for surgical intervention and cannot undergo curative radiochemotherapy, as per the 8th edition TNM staging classification of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer.
• Provide archived tumor tissue or tissue obtained from biopsy at screening for biomarker testing, including EGFR mutation status, etc.;
• Presence of EGFR positive mutation;
• Investigator confirmation of at least one measurable lesion according to RECIST 1.1 criteria.
• Patients who have previously received platinum-containing adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or radical radiochemotherapy for advanced disease, with disease progression occurring >6 months after the last treatment, may participate in this study;
• Expected life expectancy =3 months.
• ECOG PS 0-1.
• Adequate hematologic function, defined as an absolute neutrophil count =1.5×10^9/L, platelet count =100×10^9/L, hemoglobin =90g/L (without a history of blood transfusion in the past 7 days).
• Adequate liver function, defined as total bilirubin level =1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =2.5 times ULN for all patients, or for patients with liver metastasis, AST and ALT levels =5 times ULN.
• Adequate renal function, defined as serum creatinine =1.5 times ULN.
• Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) =1.5 times ULN; if a subject is on anticoagulant therapy, INR/PT should be within the therapeutic range set by the anticoagulant.
• Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, with negative results; and reliable contraception methods (such as intrauterine devices, oral contraceptives, and condoms) should be used during the trial and for 30 days after the end of the trial. Men of childbearing potential should use condoms for contraception during the trial and for 30 days after the end of the trial.
• Willingness to comply with regular follow-up visits and adhere to trial requirements.

Exclusion Criteria:

• 1. Currently participating in an interventional clinical study treatment;
• Have previously received anti-EGFR treatment;
• Received traditional Chinese medicine with antitumor indications or immunomodulatory drugs (such as thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose;
• Have a history of allergic reactions to any of the study drug components.
• Have active hemoptysis (more than half a teaspoon), active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis;
• Have tumor compression of surrounding vital organs (such as the esophagus) with accompanying related symptoms, compression of the superior vena cava, or invasion of major mediastinal vessels, the heart, etc.;
• Known to have brain metastases. Patients judged by the investigator to be asymptomatic or have stable brain metastases may be enrolled;
• Have active systemic infections, including tuberculosis (clinical diagnosis including medical history, physical examination, imaging findings, and TB testing according to local medical routines), hepatitis B (known to be HBV surface antigen (HBsAg) positive, with HBV DNA =1000cps/ml or the lower limit of the reference value), hepatitis C, or human immunodeficiency virus (HIV antibody positive);
• Known to have mental illness or substance abuse that may affect compliance with trial requirements;
• Recently treated with a full dose of oral or non-oral anticoagulants or thrombolytics. Prophylactic use of anticoagulants is allowed.
• Have a medical history, disease, treatment, or laboratory abnormality that may interfere with the trial results or prevent the subject from participating in the study throughout, or the investigator considers participation in the study not to be in the best interest of the subject.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer Non-small Cell Stage IV
• Lung Neoplasms

Intervention

Drug:
• Almonertinib
Almonertinib, dosing regimen: 110mg/day orally, once daily in a 28-day cycle, continuously. Lastet, dosing regimen: 50 mg/day orally, every 28 days in a cycle, two weeks of continuous oral administration, two weeks off.

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai
China	The First Affiliated Hospital of Xiamen University	Xiamen

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China	Shanghai Zhongshan Hospital, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	PFS is defined as the period from the start of treatment until the disease progresses or the patient dies from any cause, whichever came first, assessed up to 24 months	up to 24 months
Secondary	Disease Control Rate	Disease Control Rate (DCR) is to describe the proportion of patients who have achieved a response to treatment that includes not only complete and partial responses but also stable disease.	24 months
Secondary	Duration of Response	The Duration of Response (DoR) is a clinical measure to determine the length of time that a tumor continues to respond to treatment without the cancer worsening.	24 months
Secondary	Objective Response Rate	The Objective Response Rate (ORR) is a key metric used in oncology to assess the proportion of patients in a study or treatment group who achieve an objective response (CR or PR).	24 months
Secondary	Overall Survival	OS is measured from the date of the initiation of treatment to the date of death from any cause, whichever came first, assessed up to 24 months	up to 24 months