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

NCT03453307 | Unknown DMC

• 1 other identifier: K2OLC-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

Tumor Organoids; Drug Sensitivity; NSCLC

Outcome Measures

Primary Outcomes (1)

• Correlation of ex vivo sensitivity test on patient derived organoid models

  The drug sensitivity was tested on patient-derived tumor organoids, which is compared with clinical response of the chemo or target therapy treatment.

  12 months

Study Arms (1)

Group-1

NSCLC patients receiving chemotherapy or target therapy treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• K2 Oncology, Inc.: lead

Study Sites (1)

People's Hospital of Hebei Province

Shijiazhuang, Hebei, 050051, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor samples from surgical resection of enrolled NSCLC patients are to be collected, and subject to organoid isolation followed by ex vivo drug sensitivity test.

Study Officials

• Zhijian Sun, Dr.

  K2 Oncology, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijian Sun, Dr.

CONTACT

(86) 18201013329; zjsun@k2oncology.com

Chenggang Zhu, Dr.

CONTACT

(86) 18621958197; cgzhu@k2oncology.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: January 30, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2021
• Last Updated: March 5, 2018

Record last verified: 2018-02

Locations

CN (1)