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

• Conditions: Lung Neoplasms

• Registration Number: NCT04159337
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-08-30
• Study First Submitted: 2019-10-23
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Study First Posted: 2019-11-12
• Last Update Posted: 2019-11-12
• Primary Completion: 2022-01-01
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	through the whole study period, an average of 3 year	PFS refers to the time from initial treatment to the time of disease progression or death
Tumor Mutational Burden (TMB)	halfway of the study, an average of 1.5 year	TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases

Secondary Outcome Measures

Name	Time	Method
Other biomarkers	halfway of the study, an average of 1.5 year	The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients
Overall survival (OS)	through the whole study period, an average of 3 year	OS refers to the time from the patient entering into the group to the time of death
Clonality	halfway of the study, an average of 1.5 year	The tumor clonality in Chinese lung cancer patients

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China