Organoids Predict Therapeutic Response in Patients With Multi-line Drug-resistant Lung Cancer

NCT05669586 | Recruiting Phase 2

• 1 other identifier: 136286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, open and exploratory clinical study. The purpose of this study was to evaluate the consistency and accuracy of the organogenic (PDO) model for patients with lung cancer, to predict the clinical efficacy of anticancer drugs, and to speculate and select personalized treatment regiments for patients with lung cancer who are resistant to multi-line standard therapies.

Conditions

Lung Cancer; Organoid

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Time from randomization to any disease progression and/or death, defined according to strict RECIST (Response Evaluation Criteria in Solid Tumors) v1.1. Lesion will be assessed in comparison to baseline measurements.

  1 year

Secondary Outcomes (5)

• Overall survival

  72 weeks

• Disease control rate

  an average of 1 year

• Changes in tumor volume shrinking

  6 months

• Prediction of the response to treatment by the patient-derived organoids

  2 years

• The rate of successful generation of lung cancer organoids

  2 years

Study Arms (2)

Organoid-Guided Antitumor therapy

EXPERIMENTAL

lung cancer specimens are obtained from lung tumor surgery or biopsy or malignant pleural effusion are used to grow organoids. Then organoids are used for drug sensitivity tests to obtain the sensitivity to drugs. Patients will receive a relatively sensitive antitumor regimen based on the test results.

Drug: Antitumor therapy guided by organoid drug sensitivity test

Physician-decided Antitumor therapy

NO INTERVENTION

According to the National Comprehensive Cancer Network's (NCCN) Guidelines for lung Cancer, physicians will determine antitumor protocols or case report. They're also not sure what the drug susceptibility test says.

Interventions

Antitumor therapy guided by organoid drug sensitivity test DRUG

Antitumor therapy guided by organoid will be given to Multi-line Drug-resistant Non-small Cell Lung Cancer patients.

Organoid-Guided Antitumor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients: ≥18 years old.
• For non-small cell lung cancer confirmed by histology or cytology, there is no standard protocol recommendation in the guidelines for disease progression after multiline standard therapy.
• Expected survival ≥3 months.
• Sign informed consent.
• The patient is willing and able to adhere to the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.
• Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour
• At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.

You may not qualify if:

• Participated in clinical trials of other drugs within four weeks.
• Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
• Not accessible to biopsy and/or surgery sample.
• Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
• There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
• For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
• The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.
• Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders.
• The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid Reduced function; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included).
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• quan liu, doctor

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

quan liu, doctor

CONTACT

15995299079; quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: February 1, 2023
• Primary Completion: May 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)