Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes

NCT05792995 | Completed Phase 2

• 1 other identifier: CTGU007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Providing more theoretical basis for the prediction of the efficacy of advanced NSCLC and helping select better advantaged population of NSCLC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Compare Progression Free Survival (PFS) Regimen using RECIST 1.1.

  PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.

  approximately 24 months

Secondary Outcomes (1)

• Compare Overall Survival (OS)

  approximately 24 months

Study Arms (4)

Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

EXPERIMENTAL

Any first-line treatment that includes immunotherapy.

Drug: Sindillimab

Chemotherapy plus Immunomonotherapy

EXPERIMENTAL

Any first-line treatment that includes immunotherapy.

Drug: Sindillimab

Immunomonotherapy plus Anti-angiogenesis Therapy

EXPERIMENTAL

Any first-line treatment that includes immunotherapy.

Drug: Sindillimab

Immunomonotherapy

EXPERIMENTAL

Any first-line treatment that includes immunotherapy.

Drug: Sindillimab

Interventions

Sindillimab DRUG

Any treatment regimen that includes immunotherapy.

Also known as: Pembrolizumab, Nivolumab, Durvalumab

Chemotherapy plus Immunomonotherapy; Immunomonotherapy; Immunomonotherapy plus Anti-angiogenesis Therapy; Immunomonotherapy plus Chemotherapy plus Anti-angiogenesis Therapy

Eligibility Criteria

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

You may qualify if:

• Volunteer to participate in clinical research; fully understand and know the research and sign informed consent.
• Age ≥18 years, and ≤75years , either sex.
• Eastern Collaborative Oncology Group Performance status (ECOG PS) 0 ,1 or 2.
• Patients with NSCLC diagnosed by histopathology (according to the 8th edition of AJCC).
• Initial diagnosis patients unable to perform surgery.
• Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present.
• Normal renal function ：Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate ).
• Normal hematological function：absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\].
• Has a life expectancy of at ≥3 months.
• EGFR and ALK were negative.

You may not qualify if:

• ECOG PS \>2.
• Patients who received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy within six months.
• Patients who are receiving any other investigational agents within 30 days prior to entering the study.
• History of other malignancies (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years).
• Have no measurable lesion as defined by RECIST 1.1.
• Accompanied by other serious diseases, including but not limited to:
• Uncontrollable congestive heart failure (NYHA grade Ⅲ or Ⅳ), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or above hypertension (SBP \> 160mmhg or DBP \> 100mmhg) ; Severe active infection; Uncontrollable diabetes (refers to the high fluctuation of blood glucose, the impact on patients' life and the frequent occurrence of hypotension despite the standard insulin treatment and frequent blood glucose monitoring) ; Mental illness affecting informed consent and / or program compliance.
• Those who are allergic to the drug or its components used in the program.
• Pregnancy (confirmed by hCG test in blood or urine) or lactating women, or childbearing age subjects are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
• Those who are not considered suitable for the study by the researchers.
• Unwilling to participate in this study or unable to sign informed consent.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, Hubei, 443003, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Nivolumab; durvalumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 31, 2023
• Study Start: December 21, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

CN (1)