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

Lung Neoplasms Clinical Trial

Official title:

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566432
• Other study ID #: TRACELib002
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: Geneplus-Beijing Co. Ltd.
• Contact: Rongrong Chen, MD, PhD
• Phone: 86-10-53955678
• Email: chenrr[@]geneplus.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms
• Squamous Cell Lung Cancer

Intervention

Other:
• Observation
observe the association of ctDNA with efficacy of treatment

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Geneplus-Beijing Co. Ltd.	Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resistant mechanisms of targeted therapy	Resistant mutations will be identified from ctDNA or tissue mutations	At the time of disease progression (through study completion, an average of 1.5 years)