NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy

NCT04636047 | Unknown

• 1 other identifier: ShanghaiChest0016
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Liquid biopsy based on next-generation sequencing (NGS) method has become an increasingly powerful detection tool for clinical research and practice. As a companion diagnostic panel, circulating tumor DNA (ctDNA) assay has the considerable potential to detect the blood tumor mutation burden (bTMB), and bTMB calculated by ctDNA assay is regarded as a novel and promising biomarker for immunotherapy nowadays. Though immune checkpoint inhibitors (ICIs) in immunotherapy are highly effective but can induce severe immune-related adverse events (irAEs), which cannot be better predicted in advance. Meanwhile adoptive transfer of T cells transgenic for tumor-reactive T-cell receptors (TCR) is an attractive immunotherapeutic approach. However, clinical translation is so far limited due to challenges in the identification of suitable target antigens as well as TCRs that are concurrent safe and efficient. Definition of key characteristics relevant for effective and specific tumor rejection is essential to improve current TCR-based immunotherapy. This research is to characterize in-depth TCRs derived from HLA-mismatched allogeneic repertoire targeting different myeloperoxidase (MPO)-derived peptides presented by the same HLA-restriction element. Overall the purpose of this trial is to investigate the combined predictive biomarkers (including bTMB and HLA) related to the immunotherapy effects and the biomarker (TCR) associated with adverse reactions during immunotherapy and hold a predictive role, thus further benefit patients receiving immunotherapy, especially in the advanced stage lung cancer patients where tissue samples are unavailable.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

  PFS will be defined as the time from initial treatment to the time of disease progression or death

  through the whole study period, an average of 3 years

• Blood Tumor Mutational Burden (bTMB)

  bTMB will be defined as the total number of detected somatic mutation counts in coding regions per million bases in plasma ctDNA

  halfway of the study, an average of 1 year

Secondary Outcomes (3)

• Other biomarkers

  halfway of the study, an average of 1 year

• Clonality

  halfway of the study, an average of 1 year

• Overall survival (OS)

  through the whole study period, an average of 3 years

Interventions

The method of gene mutation detection OTHER

All samples were detected by NGS CGP panel.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients in Shanghai Chest Hospital

You may qualify if:

• Participant aged 18 or above, and gender unrestricted
• Individual with pathologically diagnosed lung cancer

You may not qualify if:

• Patients with concomitant other tumors
• Individual with severe cardiopulmonary insufficiency and hypoproteinemia
• Women who were pregnant and were during their lactation

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiaomin Niu

CONTACT

021-22200000-3403; ar_tey@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: November 19, 2020
• Study Start: November 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

CN (1)