Pharmacokinetically-guided on the Individualization of Pembrolizumab Administration in the Treatment of Lung Cancer

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Pembrolizumab with or without chemotherapy has become the standard therapy in advanced non-small cell lung cancer (NSCLC), with a fixed dose of 200mg every 3 weeks. The investigators performed this study to explore the clinical efficacy and safety of pharmacokinetic (PK)-guided pembrolizumab administration in advanced NSCLC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

1. cytologically or histologically confirmed primary NSCLC;

2. Stage IV primary NSCLC according to the International Association for the Study of Lung Cancer (IASLC) TNM Eighth Edition;

3. There must be at least one evaluable lesion judged according to RECIST1.1;

4. No sensitive mutation in EGFR and negative ALK rearrangement;

5. ≥18 years old;

6. The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-2;

7. Life expectancy of more than 3 months;

8. Bone marrow and organs (liver and kidney) function well, which can meet the conventional conditions for chemotherapy: neutrophil count ≥1.5×109/ L, platelet count ≥75×109/ L, hemoglobin ≥9g/ dL, total bilirubin ≤1.5×ULN, transaminase ≤2.5×ULN, serum creatinine ≤1.5×ULN or creatinine clearance ≥45ml/min. (ULN: upper limit of normal value);

9. For female subjects of reproductive age, urine or serum pregnancy test should be negative within 7 days prior to receiving the first study drug administration (cycle 1, day 1).If a urine pregnancy test is not confirmed negative, a blood pregnancy test is required;For men, consent must be given to use appropriate methods of contraception or surgical sterilization during the trial and for 8 weeks after the last administration of the experimental drug;

10. Signing the informed consent;

11. Good compliance, follow-up, and voluntary compliance with relevant regulations of the study.-

Exclusion Criteria:

1. Small cell lung cancer;

2. Brain metastases with hemorrhage;

3. Currently participating in interventional clinical research and treatment;

4. Past anti-tumor immunotherapy with other anti-PD-1 /PD-L1 monoclonal antibodies;

5. Have received solid organ or blood system transplantation;

6. An active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to initial administration.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic;

7. having been diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first administration of the study;Physiological dose of glucocorticoids (≤10 mg/ day of prednisone or its equivalent) is allowed;

8. A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;

9. A known history of human immunodeficiency virus (HIV 1/2 antibody positive);

10. untreated active hepatitis B