Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Fudan University
Updated on 25 January 2021


To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1.

Condition NSCLC Patients
Treatment pabolizumab, nafulizumab
Clinical Study IdentifierNCT04427475
SponsorFudan University
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have NSCLC Patients?
Do you have any of these conditions: Do you have NSCLC Patients??
Sign informed consent
The age is greater than or equal to 18 years old
There is at least one measurable focus according to the RECIST 1.1 standard
EGFR / ALK detection is not needed in patients with metastatic (stage IV) EGFR / ALK wild-type NSCLC confirmed by histology or cytology and in patients with squamous cell carcinoma
Cohort 1: patients receiving anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment Cohort 2: patients who received the second-line treatment of anti-PD-1 single drug (nafulizumab) for the progress of disease after chemotherapy with platinum containing dual drugs
ECoG score is 0, 1 or 2
No serious blood system, heart, lung, liver and kidney dysfunction and immune deficiency
Hemoglobin (HB) 9g / dl; leukocyte (WBC) 3 109 / L; neutrophil (ANC) 1.5 109 / L; platelet (PLT) 75 109 / L
Men or women of childbearing age are willing to take contraceptive measures in the experiment
Estimated survival time 3 months

Exclusion Criteria

Histologically, small cell and non-small cell mixed lung cancer
Pregnant or nursing women
Any unresponsive > CTCAE Level 2 toxicity caused by past anti-tumor treatment
Serum creatinine clearance < 30 ml / min (calculated by Cockcroft Gault formula)
Liver dysfunction, defined as
Serum (total) bilirubin > 1.5 upper limit of normal value (ULN)
Serum AST / SGOT or ALT / SGPT > 2.5 ULN (liver metastasis > 5 ULN)
Alkaline phosphatase level > 2.5 ULN (liver metastasis > 5 ULN, or bone) at baseline Transfer patients > 10 ULN)
Have a history of uncontrollable or symptomatic angina, arrhythmia or congestive heart failure
Symptomatic brain metastasis or meningeal metastasis
In the past 5 years, she has had or is suffering from other histological types of malignant tumors, except for cervical carcinoma in situ and fully treated skin basal cell carcinoma or squamous cell carcinoma
Have active, or have had and may recur autoimmune diseases. However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or no relapse without external triggers are expected
Diagnosis of immunodeficiency or systemic hormone therapy (e.g., hormone therapy equivalent to > 10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days before the first administration
Patients with known history of human immunodeficiency virus (HIV) infection and / or acquired immunodeficiency syndrome. Subjects with active hepatitis B or active hepatitis C
Grade 2 pneumonia caused by radiotherapy and chemotherapy (grade 2 pneumonia without systemic hormone treatment recovers to grade 1 or below within 14 days, if the researcher judges that there is no risk of recurrence, it can be included in the group for screening)
Have interstitial lung disease and the disease has symptoms
During the study period, radiotherapy is planned for the target focus
Plan to use other anti-tumor therapy during the study period
Patients with serious or uncontrolled systemic diseases who are not suitable for the study or may affect the compliance of the other party's case. Subjects' complications or other conditions may affect compliance with the protocol or may not be suitable for the study
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