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

NCT05226728 | Completed Phase 1

• 1 other identifier: GASTO 1054
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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 study to explore the clinical efficacy and safety of pharmacokinetic (PK)-guided pembrolizumab administration in advanced NSCLC.

Conditions

Non-small Cell Lung Cancer

Keywords

Pembrolizumab; Pharmacokinetics; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  median progression-free survival

  18 months

Study Arms (1)

pharmacokinetic-guided pembrolizumab cohort

EXPERIMENTAL

Eligible patients received pembrolizumab 200mg every 3 weeks with or without chemotherapy for four cycles, then for patients without progressive disease, pembrolizumab was administrated in new dose-intervals according to steady state plasma-concentration (Css) of pembrolizumab until disease progression.

Drug: pembrolizumab

Interventions

pembrolizumab DRUG

Eligible patients received pembrolizumab 200mg every 3 weeks with or without chemotherapy for four cycles, then for patients without progressive disease, pembrolizumab was administrated in new dose-intervals according to steady state plasma-concentration (Css) of pembrolizumab until disease progression

Also known as: keytruda

pharmacokinetic-guided pembrolizumab cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Wang N, Zheng L, Li M, Hou X, Zhang B, Chen J, Li S, Chen L. Clinical efficacy and safety of individualized pembrolizumab administration based on pharmacokinetic in advanced non-small cell lung cancer: A prospective exploratory clinical trial. Lung Cancer. 2023 Apr;178:183-190. doi: 10.1016/j.lungcan.2023.02.009. Epub 2023 Feb 15.

  PMID: 36868179 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Likun Chen

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: February 7, 2022
• Study Start: October 10, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

CN (1)