Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients

NCT04566432 | Recruiting

• 1 other identifier: TRACELib002
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.

Conditions

Lung Neoplasms; Lung Cancer, Nonsmall Cell; Adenocarcinoma of Lung; Squamous Cell Lung Cancer

Keywords

Next Generation Sequencing (NGS); Liquid biopsy; Immune Checkpoint Inhibitor; Whole Transcriptome Sequencing

Outcome Measures

Primary Outcomes (1)

• the evolution of ctDNA mutation profile during treatment

  ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance

  every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)

Secondary Outcomes (1)

• Resistant mechanisms of targeted therapy

  At the time of disease progression (through study completion, an average of 1.5 years)

Study Arms (2)

Immune checkpoint inhibitors

Other: Observation

Targeted therapy

Targeting ALK, ROS1, MET ex14 skipping

Other: Observation

Interventions

Observation OTHER

observe the association of ctDNA with efficacy of treatment

Immune checkpoint inhibitors; Targeted therapy

Eligibility Criteria

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

Study Population

treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma

You may qualify if:

• Provision of informed consent
• Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
• No EGFR mutation in tissue and ctDNA
• Received immune checkpoint inhibitors as the first line therapy
• ECOG performance status 0-2 with expected more than 6 months of survival time
• Willingness to comply with required protocols and give permission to use the data for clinical research and products development

You may not qualify if:

• Patients have other primary cancers
• Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
• Patients failed in either plasma or tissue sample QC

Sponsors & Collaborators

• Geneplus-Beijing Co. Ltd.: lead
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (including plasma, white cells), tissue

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Rongrong Chen, MD, PhD

CONTACT

86-10-53955678; chenrr@geneplus.org.cn

Lianpeng Chang, MS

CONTACT

86-10-53955678; changlp@geneplus.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: September 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)