Clinical trial NCT03453307: Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients
Official title: The Correlation Study of the Drug Sensitivity Between Ex Vivo Model of Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Organoids and Clinical Response in NSCLC Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Keywords: Tumor Organoids
Drug Sensitivity
NSCLC
Lead sponsor: K2 Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic NSCLC patients with axillary and other region lymph nodes metastasis. The biopsy and/or surgery tissue samples of metastatic and/or primitive tumor are accessible.

Brief summary: This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.

Detailed description: Methods - Open label single arm observatory comparison experiment

1. Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients.
2. The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test.
3. The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years old or more;
* Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis;
* Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor;
* No clinical evidence of other malignancy, unstable complication or uncontrolled infection;
* Life expectancy \> 12 months.
* Informed and signed consent by the patient.

Exclusion Criteria:

* Not accessible to biopsy and/or surgery sample;
* Patient already enrolled in another clinical trial with another first line of chemotherapy;
* Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria;
* Women who are pregnant, plan to become pregnant or are lactating during the study;
* Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found;
* Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies;
* Have other malignant tumor previously;
* Have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions;
* State of health can't finish the study;
* Patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study.
* No self-determination or refuse to participant.
* With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.

Primary outcomes:
measure: Correlation of ex vivo sensitivity test on patient derived organoid models
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: People's Hospital of Hebei Province
state: Hebei
Study officials:
affiliation: K2 Oncology, Inc.
name: Zhijian Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
References: