NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159337
• Other study ID #: ShanghaiChest0015
• Status: Recruiting
• Start date: August 30, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2019
• Source: Shanghai Chest Hospital
• Contact: Niu Xiaomin
• Phone: 021-22200000-3403
• Email: ar_tey[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Description:

Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant aged 18 or above, and gender unrestricted

• Individual with pathologically diagnosed lung cancer

Exclusion Criteria:

• Patients with concomitant other tumors

• Individual with severe cardiopulmonary insufficiency and hypoproteinemia

• Women who were pregnant and were during their lactation

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Other:
• The method of gene mutation detection
All samples were detected by large-panel, whereas some of which were also detected by WES.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	PFS refers to the time from initial treatment to the time of disease progression or death	through the whole study period, an average of 3 year
Primary	Tumor Mutational Burden (TMB)	TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases	halfway of the study, an average of 1.5 year
Secondary	Other biomarkers	The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients	halfway of the study, an average of 1.5 year
Secondary	Clonality	The tumor clonality in Chinese lung cancer patients	halfway of the study, an average of 1.5 year
Secondary	Overall survival (OS)	OS refers to the time from the patient entering into the group to the time of death	through the whole study period, an average of 3 year