A Single-arm Clinical Study of Anlotinib Combined With Penpulimab Plus SBRT in Metastatic Non-Small Cell Lung Cancer (NSCLC)

Peking University Third Hospital0 sites32 target enrollmentSeptember 12, 2022

ConditionsNon-Small Cell Lung Cancer

Interventionspenpulimab SBRT Anlotinib Hydrochloride

DrugsAnlotinib Hydrochloride penpulimab

Overview

Phase: Phase 2
Intervention: penpulimab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Peking University Third Hospital
Enrollment: 32
Primary Endpoint: Progression-free Survival
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will explore the effectiveness and safety of the combination therapy of anlotinib , penpulimab and SBRT in patients with metastatic non-small Cell Lung Cancer (NSCLC)

Registry

clinicaltrials.gov

Start Date

September 12, 2022

End Date

October 15, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years, no gender limit；
•Histological or cytological diagnosis of stage IV non-small cell lung cancer（NSCLC）
•The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up.
•Patients with advanced NSCLC who have received one or two systemic treatments, and those who are unwilling to accept or cannot tolerate systemic chemotherapy can also be enrolled. If it is a driver gene mutation-positive (EGFR, ALK) patient, it must be accepted after receiving the corresponding targeted therapy resistance or intolerable toxicity, No secondary susceptible mutations were eligible for enrollment.
•Has at least five disseminated lesions for SBRT , and measurable lesion that meets the RECISTv1.1 standard。
•Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
•The expected survival time ≥ 3 months;
•The functions of important organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the research treatment): Absolute Neutrophil Count (ANC) ≥1.5×10 E+9/L, Hemoglobin (HB) ≥9g/dL, Platelets (PLT)≥90×10 E+9/L, Serum Albumin (ALB)≥2.8g/dL, Total Bilirubin (TBIL) ≤1.5 ULN, ALT、AST≤2.5 UILN(If abnormal liver function is caused by liver metastasis, ≤5 ULN), Serum creatinine sCr≤1.5 ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula) , Normal thyroid function;
•For female subjects of childbearing potential, a serum pregnancy test should be performed within 7 days prior to the administration of the first study intervention (study drug, radiation therapy) and have a negative result. Subjects are required to agree to use highly effective contraception and continue until at least 120 days after discontinuation of trial treatment

Exclusion Criteria

•The lesion has received prior radiotherapy and is not suitable for SBRT;
•Currently participating in interventional clinical research and treatment, or receiving other research drugs or treatment with research equipment within 4 weeks before the first administration;
•Imaging (CT or MRI) shows evidence of tumour invasion of large blood vessels or poorly demarcated blood vessels or the presence of cavities and necrotic lesions in the lungs；
•With active bleeding or perforation or a hereditary or acquired bleeding tendency present, with a daily haemoptysis of ≥2.5mL in the 3 months prior to screening.
•Suffer from active autoimmune diseases that require hormone or immunomodulatory treatment;
•Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the study drug for the first time, or the adverse events caused by the previously received drug have not recovered (ie ≤ grade 1 or reached the baseline level). Note: Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
•Patients with multiple factors that affect oral medications (eg, inability to swallow, chronic diarrhea, and intestinal obstruction).
•Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
•Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis, and HIV;
•Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;

Arms & Interventions

Anlotinib combined with SBRT and penpulimab

Intervention: penpulimab

Anlotinib combined with SBRT and penpulimab

Intervention: SBRT

Anlotinib combined with SBRT and penpulimab

Intervention: Anlotinib Hydrochloride

Outcomes

Primary Outcomes

Progression-free Survival

Time Frame: Time Frame: up to approximately 2 year

Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)

Secondary Outcomes

incidence, type and severity of adverse events(Time Frame: up to approximately 2 year)
Objective response rate(Time Frame: up to approximately 1 year)
Overall Survival(Time Frame: up to approximately 2 year)