Brief Title
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients
Official Title
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy
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.
Detailed 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.
Study Type
Observational
Primary Outcome
the evolution of ctDNA mutation profile during treatment
Secondary Outcome
Resistant mechanisms of targeted therapy
Condition
Lung Neoplasms
Intervention
Observation
Study Arms / Comparison Groups
Immune checkpoint inhibitors
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
250
Start Date
July 1, 2020
Completion Date
June 30, 2023
Primary Completion Date
December 31, 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 86-10-53955678, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04566432
Organization ID
TRACELib002
Responsible Party
Sponsor
Study Sponsor
Geneplus-Beijing Co. Ltd.
Collaborators
Shanghai Chest Hospital
Study Sponsor
, ,
Verification Date
March 2022