Status:
COMPLETED
Pharmacokinetically-guided on the Individualization of Pembrolizumab Administration in the Treatment of Lung Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 st...
Detailed Description
In this prospective, open-label, single-arm exploratory study, the investigators enrolled advanced NSCLC patients without sensitizing EGFR or ALK mutation in Sun yat-sen university cancer center. Elig...
Eligibility Criteria
Inclusion
- cytologically or histologically confirmed primary NSCLC;
- Stage IV primary NSCLC according to the International Association for the Study of Lung Cancer (IASLC) TNM Eighth Edition;
- There must be at least one evaluable lesion judged according to RECIST1.1;
- No sensitive mutation in EGFR and negative ALK rearrangement;
- ≥18 years old;
- The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-2;
- Life expectancy of more than 3 months;
- 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);
- 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;
- Signing the informed consent;
- Good compliance, follow-up, and voluntary compliance with relevant regulations of the study.-
Exclusion
- Small cell lung cancer;
- Brain metastases with hemorrhage;
- Currently participating in interventional clinical research and treatment;
- Past anti-tumor immunotherapy with other anti-PD-1 /PD-L1 monoclonal antibodies;
- Have received solid organ or blood system transplantation;
- 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;
- 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;
- A history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
- A known history of human immunodeficiency virus (HIV 1/2 antibody positive);
- untreated active hepatitis B
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05226728
Start Date
October 10 2018
End Date
February 1 2021
Last Update
February 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000