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Validation Study on the Concordance Between Drug Sensitivity Testing in Advanced NSCLC Tumor Organoid-Immune Cell Co-cultures and the Clinical Efficacy of Immune Checkpoint Inhibitors

Validation Study on the Consistency between Drug Sensitivity Testing of Late-Stage NSCLC Tumor Organoid-Immune Cell Co-Culture models and Clinical Efficacy of Immune Checkpoint Inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119930
Enrollment
Unknown
Registered
2026-03-05
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Non-small cell lung cancer observation group:None

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, pathologically confirmed advanced NSCLC (stage IV); 2. Plan to receive single-agent immunotherapy such as PD-1/PD-L1 monoclonal antibody; 3. Adequate tumor tissue (biopsy or surgical specimen) and peripheral blood samples can be obtained; 4. ECOG score = 3 months; 5. Sign the informed consent form; 6. Color Doppler echocardiography indicates that the cardiac ejection fraction is within the normal range, and other organ functions are good and meet the following indicators: hemoglobin >= 90g/L; white blood cells >= 3.5×10^9/L; platelets >= 100×10^9/L; neutrophils >= 1.5×10^9/L; aspartate aminotransferase not greater than 3 times the upper limit of normal; alanine aminotransferase not greater than 3 times the upper limit of normal; bilirubin not greater than 1.5 times the upper limit of normal; serum creatinine value not greater than 1.25 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: 1.There are contraindications for immunotherapy (such as active autoimmune diseases, interstitial lung disease); 2.The patient has previously received the same type of immunotherapy; 3.The quality of tumor tissue or blood samples does not meet the standards; 4.The patient has other malignant tumors or has suffered from malignant tumors other than lung cancer within the past 5 years; 5.The patient has serious diseases other than non-malignant tumors that affect the patient's compliance or put the patient at risk for immunotherapy; 6.Severe liver dysfunction, liver function classification (Child-Pugh) grade C; 7.Severe heart dysfunction, with heart function at grade III or above; 8.Severe kidney dysfunction, including patients in the end-stage of renal failure or in the uremic stage

Design outcomes

Primary

MeasureTime frame
Progression-free survival period;Objective remission rate(ORR);Drug sensitivity;

Secondary

MeasureTime frame
Overall survival ;

Countries

China

Contacts

Public ContactLi Yong

The Second Affiliated Hospital of Xi'an Jiaotong University

liyong19831@163.com+86 29 8651 8588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026