Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Dimercaprol

Single arm of Olmutinib, staring dose of 800 mg

Patients to be provided with Olmutinib 800mg (2 x 400 mg tablets) once daily (QD)

Olmutinib

Kye Young Lee

The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from extracellular vesicles of bronchoalveolar lavage fluid.

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of Olmutinib(Olita®) administered to patients with T790M-positive NSCLC confirmed using DNA extracted from extracellular vesicles in bronchoalveolar lavage fluid as measured by objective response rate (ORR).

Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA

Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid

defined as the proportion of patients who achieved complete remission(CR) or partial remission(PR) based on RECIST version 1.1

defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1

defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first

Hanmi Pharmaceutical Company Limited

Konkuk University Medical Center

Professor

Multiple Pulmonary Nodules

We will enroll 300 pulmonary nodules penplein this study. After bronchoscopy, surgical examination or clinical follow-up, pulmonary nodules were finally diagnosed as malignant or benign.

We will enroll 100 healthy penple in this study. After bronchoscopy, surgical examination or clinical follow-up, pulmonary nodules were finally diagnosed as malignant or benign.

Through the detection and analysis of blood and alveolar lavage fluid of 300 patients with pulmonary nodules and 100 healthy population, the diagnostic efficacy of ctDNA and exosomes combined detceion will be studied.

ctDNA and Exosome Combined Detection

Jiayuan Sun

Jiayuan Sun, PhD

This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

Pulmonary nodules are round or irregular shape lesions with a diameter of less than or equal to 3cm. 10% lung nodules will become lung cancer, and lung cancer is evolved from small nodules.

Liquid biopsy is an effective and noninvasive means to assist in the early diagnosis of lung cancer, including circulating tumor cell、exosome and ctDNA detection. CtDNA is used to detect DNA fragments relesased to plasma by cracking or apoptotic tumor cells. Exosomes are derived from living cells, and researchers found that exosome nucleic acid detection of living cells may be closely related to the dynamic development of tumors.

This study through the detection of EGFR、ALK、ROS1、KRAS、HER2、BARF、NTRG1 seven ctDNA and exosome RNA in the blood and alveolar lavage of lung nodules patients and heavy smoking healthy population. If the results of ctDNA test is positive, the target nodule is malignant; if the reaults of ctDNA teste is negatie but exocome RNA is positive, the target nodule is also malignant. If the results of both tests are negtive, the target nodule is recognized as benign. The purpose is study the sensitivity, specificity and diagnostic accuracy of ctDNA and exosome combined detection in the identification of benign and malignant pulmonary nodules. Besides, the diagnostic efficacy of different specimens including blood and alveolar lavage in the identification of benign and malignant pulmonary nodules is also studied.

In this study, 12ml blood was extracted before bronchoscopy and 15ml bronchoalveolar lavage fluid was collected during bronchoscopy.

Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules

Immunohistochemical method was used in ctDNA and exosome combined detection, to detect the blood and alveolar lavage of healthy people and patients with pulmonary nodules.Using the final diagnosis as the standard, the gene mutation threshold of benign and malignant lesions were demarcated, and the differences in gene expression between different types of diseases and the differences in diagnostic rates of blood and alveolar lavage fluid were explored.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA	NCT03228277	Non Small Cell ...	Olmutinib	19 Years -	Konkuk University Medical Center
Clinical Study of ctDNA and Exosome Combined Detection to Identify Benign and Malignant Pulmonary Nodules	NCT04182893	Pulmonary Nodul...	ctDNA and Exoso...	18 Years - 80 Years	Shanghai Chest Hospital

Spots Global Cancer Trial Database for bronchoalveolar lavage fluid