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Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

Primary Purpose

Malignant Tumor of Lung, Poor Performance Status

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Almonertinib
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Tumor of Lung focused on measuring Almonertinib, Non-Small Cells Lung Cancer, poor performance status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Male or female who is over 18 years old. Malignant tumorsr proved by pathology. NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing. PS score of 2-4; this score is caused by complications caused by the tumor and cannot be improved by any non-anti-tumor means. Patients with brain metastases may be enrolled at the discretion of the investigator. Appropriate organ system function. Exclusion Criteria: Patients who have previously used any antineoplastic drugs。 Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer); Genetic testing results in patients with rare EGFR genotypes (G719X, E709X, Del18 on exon 18, Ins19 on exon 19, Ins20, S768I on exon 20, and L861Q on exon 21). Patients with other mutations (ALK, Ros-1, C-MET). Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer; Participated in other clinical trials within 4 weeks before the start of the study; patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency; Allergic to any ingredient in the drug; Patients with abnormal coagulation function, receiving thrombolysis or anticoagulation therapy, bleeding tendency or have clear gastrointestinal bleeding concerns; Hyperactive/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred in 6 months before the start of the study; Wound or fracture has not been healed for a long time; urinary protein was greater than ++ and 24-hour urinary protein quantification #1.0 g. Severe or uncontrolled infections; Substance abuse or mental disorder; Objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary function; Immunodeficiency, including being HIV-positive, or having other acquired, congenital immunodeficiency diseases, or having a history of organ transplantation; Other malignant tumors within 5 years, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix; Who have received VEGFR inhibitors, such as sorafenib and sunitinib, etc.; pregnant or lactating women; the researchers considered it unsuitable for inclusion。

Sites / Locations

  • Zhou ChengzhiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Almonertinib

Arm Description

Almonertinib, 110 mg, po, QD; 28 days every cycle

Outcomes

Primary Outcome Measures

ORR
Objective Response Rate
Time of PS score change from 2~4 to 1
Time of performance status score change from 2~4 to 1

Secondary Outcome Measures

PFS
Median progression-free survival
OS
Median overall survival
DCR
Disease control rate

Full Information

First Posted
February 5, 2022
Last Updated
April 12, 2023
Sponsor
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT05826483
Brief Title
Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status
Official Title
Exploration of the Clinical Application of Almonertinib in the First-line Treatment of Patients With EGFR Mutation-positive Advanced Non-small Cell Lung Cancer With Poor Performance Status
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore, the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Detailed Description
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.In recent years, systemic treatments with good efficacy and low toxicity, such as gene-targeted therapy, anti-angiogenic therapy and immunotherapy, have largely replaced single chemotherapy, and have great potential to benefit from existing treatments for poor PS scores of advanced lung cancer patients can adopt more aggressive treatment strategies.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore,the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Tumor of Lung, Poor Performance Status
Keywords
Almonertinib, Non-Small Cells Lung Cancer, poor performance status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment Almonertinib monotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almonertinib
Arm Type
Experimental
Arm Description
Almonertinib, 110 mg, po, QD; 28 days every cycle
Intervention Type
Drug
Intervention Name(s)
Almonertinib
Intervention Description
Almonertinib Mesilate Tablets
Primary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
24 months
Title
Time of PS score change from 2~4 to 1
Description
Time of performance status score change from 2~4 to 1
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PFS
Description
Median progression-free survival
Time Frame
24 months
Title
OS
Description
Median overall survival
Time Frame
from baseline until death due to any cause, up to a maximum of approximately 4years
Title
DCR
Description
Disease control rate
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Safety: Dose-limiting toxicities
Description
Any level 3 or greater toxicity
Time Frame
from the screening period to 28 days after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Male or female who is over 18 years old. Malignant tumorsr proved by pathology. NSCLC patients with EGFR mutation (19 deletion/21 L858R point mutation) or primary T790M mutation in pre-enrollment genetic testing. PS score of 2-4; this score is caused by complications caused by the tumor and cannot be improved by any non-anti-tumor means. Patients with brain metastases may be enrolled at the discretion of the investigator. Appropriate organ system function. Exclusion Criteria: Patients who have previously used any antineoplastic drugs。 Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer); Genetic testing results in patients with rare EGFR genotypes (G719X, E709X, Del18 on exon 18, Ins19 on exon 19, Ins20, S768I on exon 20, and L861Q on exon 21). Patients with other mutations (ALK, Ros-1, C-MET). Imperfection of upper gastrointestinal physiology, or absorption disorder syndrome, or inability to tolerate oral drugs, or active peptic ulcer; Participated in other clinical trials within 4 weeks before the start of the study; patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure > 140mmhg, diastolic blood pressure > 90mmhg), myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency; Allergic to any ingredient in the drug; Patients with abnormal coagulation function, receiving thrombolysis or anticoagulation therapy, bleeding tendency or have clear gastrointestinal bleeding concerns; Hyperactive/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism occurred in 6 months before the start of the study; Wound or fracture has not been healed for a long time; urinary protein was greater than ++ and 24-hour urinary protein quantification #1.0 g. Severe or uncontrolled infections; Substance abuse or mental disorder; Objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of pulmonary function; Immunodeficiency, including being HIV-positive, or having other acquired, congenital immunodeficiency diseases, or having a history of organ transplantation; Other malignant tumors within 5 years, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix; Who have received VEGFR inhibitors, such as sorafenib and sunitinib, etc.; pregnant or lactating women; the researchers considered it unsuitable for inclusion。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Chengzhi, MD
Phone
13560351186
Email
doctorzcz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Chengzhi, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Zhou Chengzhi
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengzhi Zhou, Professor
Phone
13560351186
Email
doctorzcz@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan

Learn more about this trial

Almonertinib in the First-line Treatment of Patients of NSCLC With Poor Performance Status

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