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

Not Applicable

• Conditions: NSCLC Patients
• Interventions: Drug: nafulizumab; Drug: pabolizumab

• Registration Number: NCT04427475
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-08
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Sign informed consent.
2. The age is greater than or equal to 18 years old.
3. There is at least one measurable focus according to the RECIST 1.1 standard
4. 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.
5. 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
6. ECoG score is 0, 1 or 2.
7. No serious blood system, heart, lung, liver and kidney dysfunction and immune deficiency.
8. Hemoglobin (HB) ≥ 9g / dl; leukocyte (WBC) ≥ 3 * 109 / L; neutrophil (ANC) ≥ 1.5 * 109 / L; platelet (PLT) ≥ 75 * 109 / L.
9. Men or women of childbearing age are willing to take contraceptive measures in the experiment.
10. Estimated survival time ≥ 3 months.

Exclusion Criteria

1. Histologically, small cell and non-small cell mixed lung cancer.

2. Pregnant or nursing women.

3. Any unresponsive > CTCAE Level 2 toxicity caused by past anti-tumor treatment

4. Serum creatinine clearance < 30 ml / min (calculated by Cockcroft Gault formula)

5. Liver dysfunction, defined as:

   1. Serum (total) bilirubin > 1.5 × upper limit of normal value (ULN)
   2. Serum AST / SGOT or ALT / SGPT > 2.5 × ULN (liver metastasis > 5 × ULN)
   3. Alkaline phosphatase level > 2.5 × ULN (liver metastasis > 5 × ULN, or bone) at baseline Transfer patients > 10 × ULN)

6. Have a history of uncontrollable or symptomatic angina, arrhythmia or congestive heart failure.

7. Symptomatic brain metastasis or meningeal metastasis.

8. 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.

9. 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.

10. 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.

11. Patients with known history of human immunodeficiency virus (HIV) infection and / or acquired immunodeficiency syndrome. Subjects with active hepatitis B or active hepatitis C

12. 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).

13. Have interstitial lung disease and the disease has symptoms.

14. During the study period, radiotherapy is planned for the target focus.

15. Plan to use other anti-tumor therapy during the study period.

16. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nafulizumab	nafulizumab	Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.
pabolizumab	pabolizumab	Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles.

Primary Outcome Measures

Name	Time	Method
PD-L1 expression profiles of exosomes	through study completion, an average of 1 year	detect the difference of PD-L1 expression profiles of exosomes in NSCLC patients before and after immunotherapy
miRNA expression profiles of exosomes	through study completion, an average of 1 year	detect the difference of miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China