Therapeutic ResistAnce and Clonal Evolution of ICIs

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Brief Title

Therapeutic ResistAnce and Clonal Evolution of ICIs

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

December 31, 2022

Primary Completion Date

June 30, 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

September 2020