Clinical trial NCT04566432: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Chest Hospital
First posted: 2020-09-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma

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.

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

Primary outcomes:
measure: the evolution of ctDNA mutation profile during treatment
timeFrame: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)
Secondary outcomes:
measure: Resistant mechanisms of targeted therapy
timeFrame: At the time of disease progression (through study completion, an average of 1.5 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: