Combined Statin and PD-1/PD-L1 Inhibitors in Treating Non-small Cell Lung Cancer

NCT05636592 | Active Not Recruiting FDA Drug

• 1 other identifier: K2022145
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study was designed to evaluate the safety and efficacy of PD-1/PD-L1 inhibitors in combination with statins compared with treatment with PD-1/PD-L1 inhibitors alone in advanced NSCLC patients. Participants will receive either immunotherapy + statin or immunotherapy until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• objective response rate

  Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases

  three years

• progression-free survival

  Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause

  three years

Secondary Outcomes (1)

• overall survival

  five years

Study Arms (2)

Standard programme group

Standard programme group, immunotherapy alone

controlled programme group

controlled programme group, statin combined with immunotherapy

Drug: immunotherapy

Interventions

immunotherapy DRUG

statin combined with immunotherapy

controlled programme group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

According to indications of statins, the enrolled people are divided into statin group and non-statin group.

You may qualify if:

• Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy
• Not applicable to EGFR/ALK/ROS1 targeted therapy
• Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements
• Patients have never received PD-1/PD-L1/CTLA-4 inhibitors treatment throughout the body for phase IIIB or IV NSCLC
• Patient have indications for statins
• The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1
• The expected lifetime is more than 12 weeks
• The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study)

You may not qualify if:

• Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group
• Currently participating in interventional clinical research treatment, or received other research drugs or used research devices within 4 weeks before the first administration
• Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration
• The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone ≤ 10mg/day or equivalent)
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• According to the instructions of statins, there are contraindications to the use of statins
• People who are allergic to any component of the drug
• People with multiple factors affecting oral medicine (such as inability to swallow, gastrointestinal resection, significant digestive system diseases that may interfere with absorption, metabolism or excretion, such as chronic diarrhea or intestinal obstruction)

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Kai Wang, PhD

  The Fourth Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 5, 2022
• Study Start: October 15, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)