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

NCT05826483 | Unknown Phase 1

• 1 other identifier: CROC202201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Tumor of Lung; Poor Performance Status

Keywords

Almonertinib; Non-Small Cells Lung Cancer; poor performance status

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Response Rate

  24 months

• Time of PS score change from 2~4 to 1

  Time of performance status score change from 2\~4 to 1

  6 months

Secondary Outcomes (3)

• PFS

  24 months

• OS

  from baseline until death due to any cause, up to a maximum of approximately 4years

• DCR

  24 months

Other Outcomes (1)

• Safety: Dose-limiting toxicities

  from the screening period to 28 days after treatment completion

Study Arms (1)

Almonertinib

EXPERIMENTAL

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

Drug: Almonertinib

Interventions

Almonertinib DRUG

Almonertinib Mesilate Tablets

Almonertinib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

RECRUITING

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

• Zhou Chengzhi, MD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhou Chengzhi, MD

CONTACT

13560351186; doctorzcz@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of pneumology department, Principal Investigator, Clinical Professor

Model Details: Single Group Assignment Almonertinib monotherapy

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: April 24, 2023
• Study Start: January 1, 2022
• Primary Completion: December 28, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)