Patient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer

Patient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer: a Prospective, Observational Study

This trial is a prospective, observational study of non-small cell lung cancer that aims to evaluate the feasibility, preliminary efficacy and safety of patient-derived tumor-like cell cluster model in guiding the precision treatment strategy.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: PTC predicts the response to drug therapy in lung cancer patients

Detailed Description

The investigators have established a precision treatment strategy, that select immunotherapy drugs or chemotherapeutic drugs or targeted drugs based on information from PTCs drug-screening or/and bioinformatic prediction. In this study, the investigators are going to exploit this strategy for the precision treatment of advanced stage non-small cell lung cancer (NSCLC). The investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, objective response rate, progression free survival etc. In addition, investigators will investigate the changes in the tumor immune microenvironment during drug treatment.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Hang Su, Ph.D, MD; Phone Number: 13917910850; Email: dreamsuhang@163.com
      • Contact: Yajuan Cao, Ph.D, MD; Phone Number: 13524141612

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Non-small cell lung cancer diagnosed by pathology (including histology or cytology)

Description

Inclusion Criteria:

1. Age: ≥18 years and ≤80 years;
2. Non-small cell lung cancer diagnosed by pathology (including histology or cytology);
3. Having measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumour lesion is ≥10mm, the short diameter of CT scan of lymph node lesion is ≥15mm, the thickness of scanning layer is not more than 5mm, and the measurable lesion has not received local treatment such as radiotherapy, cryotherapy, etc.);
4. ECOG PS: 0-2 points;
5. Expected survival ≥ 3 months;
6. Adequate hepatic function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN) and alanine aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the ULN in all patients;
7. Adequate renal function, defined as creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula);
8. Adequate coagulation function, defined as International Normalised Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; if the subject is on anticoagulant therapy, as long as the INR/PT is within the range formulated for the anticoagulant drug;
9. For female subjects of childbearing potential, a negative urine or serum pregnancy test should be presented within 3 days prior to receiving the first dose of study drug, or a blood pregnancy test will be requested if the urine pregnancy test result cannot be confirmed as negative;
10. If there is a risk of conception, male and female patients are required to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) for at least 180 days after discontinuation of trial treatment; NOTE: Abstinence is acceptable as a method of contraception if abstinence is the subject's usual lifestyle and preferred method of contraception;
11. Subjects voluntarily enroll in the study, sign a written informed consent prior to the implementation of any trial-related process, are compliant, and cooperate with follow-up visits.

Exclusion Criteria:

1. Currently participating in an interventional clinical study treatment, or have received another investigational drug or investigational device within 4 weeks prior to the first dose;
2. Have received a proprietary medicine with an anti-tumor indication or an immunomodulatory drug (thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose, or have received major surgical treatment within 3 weeks prior to the first dose;
3. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastases requiring clinical intervention;
4. Known or screening test findings of active central nervous system (CNS) metastases and/or carcinomatous meningitis;
5. Has received a solid organ or blood system transplant;
6. Class III-IV congestive heart failure (New York Heart Association classification) with poorly controlled and clinically significant arrhythmias;
7. Any arterial thrombosis, embolism or ischemia such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to enrolment for treatment. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to enrolment (implantable IV port or catheter-derived thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolism);
8. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy;
9. Patients requiring long-term systemic corticosteroids. Patients requiring intermittent use of bronchodilators, inhaled corticosteroids, or locally injected corticosteroids due to COPD, asthma may be enrolled;
10. Diagnosis of other malignancy within 5 years prior to the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ, and if diagnosed with other malignancy or lung cancer more than 5 years prior to the dose, pathological or cytological diagnosis of recurrent metastatic lesions is required;
11. Known psychiatric or substance abuse conditions that may have an impact on compliance with the trial requirements;
12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis;
13. untreated active hepatitis B; Note: Subjects with hepatitis B who meet the following criteria are also eligible for enrolment: HBV viral load must be <1000 copies/ml (200 IU/ml) or below the lower limit of detection prior to the first dose of drug, and subjects should be treated with anti-HBV therapy to avoid viral reactivation for the entire duration of the study chemotherapeutic agent treatment. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required but close monitoring of viral reactivation is needed;
14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
15. Live vaccination within 30 days prior to the first dose; NOTE: It is permissible to receive injectable inactivated viral vaccine against seasonal influenza; however, it is not permissible to receive live attenuated influenza vaccine administered intranasally;
16. The presence of abnormal results from a medical history, disease, treatment, or laboratory that could interfere with the results of the trial, prevent the subject from participating in the study throughout its duration, or where participation in the study is not, in the opinion of the Investigator, in the best interest of the subject;
17. Local or systemic disease, or secondary reactions to cancer, not due to malignancy and which may result in a higher medical risk and/or uncertainty in the evaluation of survival.
18. Persons who, in the opinion of the investigator, are not suitable for inclusion.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTC drug-testing high response group	Diagnostic test: PTC predicts the response to drug therapy in lung cancer patients; a Prospective, Observational Study
PTC drug-testing low response group	Diagnostic test: PTC predicts the response to drug therapy in lung cancer patients; a Prospective, Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance Rate between PTC drug-sensitivity results and clinical response	Clinical response is evaluated according to RECIST 1.1 criteria. Concordance rate is defined as the percentage of participants whose clinical response (Complete Response or Partial Response) matches the predicted sensitivity by the PTC assay.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	The progression free survival between PTC drug-testing high group with PTC drug-testing low group	3 years
Difference in Proportion of Tumor-Infiltrating Immune Cell Subsets (e.g., T cells, B cells, Macrophages).	Evaluated by single-cell RNA sequencing (scRNA-seq) or transcriptomic analysis on samples (pleural effusion, biopsy, etc.). Data will be reported as the percentage of specific immune cell types (e.g., CD4+, CD8+ T cells, Tregs, M1/M2 macrophages) relative to total cells, comparing the PTC drug-testing high group with the low group.	6 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Patient-derived Tumor-like Cell Cluster; Precision Treatment Strategy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: STAR015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No