Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients

• Conditions: NSCLC

• Registration Number: NCT03453307
• Lead Sponsor: K2 Oncology, Inc.

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.

Study Timeline

• Study Start: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-03-05
• Last Update Posted: 2018-03-05
• Primary Completion: 2020-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of ex vivo sensitivity test on patient derived organoid models	12 months	The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.

Trial Locations

Locations (1)

People's Hospital of Hebei Province; 🇨🇳 Shijiazhuang, Hebei, China