Anlotinib , Penpulimab Combined With SBRT for Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT05485350

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2024-10-15

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)

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib combined with SBRT and penpulimab

Group Type: EXPERIMENTAL

Anlotinib Hydrochloride

Intervention Type: DRUG

12 mg/d, d1-14, q3w

penpulimab

Intervention Type: DRUG

200mg, ivgtt, d1, q3w

SBRT

Intervention Type: RADIATION

55-180Gy

Interventions

Anlotinib Hydrochloride

12 mg/d, d1-14, q3w

Intervention Type: DRUG

penpulimab

200mg, ivgtt, d1, q3w

Intervention Type: DRUG

SBRT

55-180Gy

Intervention Type: RADIATION

Other Intervention Names

AL3818; Anlotinib Hydrochloride Capsules; FuKeWei; AK105

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;
• Suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
• Live vaccines have been vaccinated within 4 weeks before the first use of the study drug.
• Active or previously documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
• Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/day prednisone or other equivalent therapeutic hormones), and still within 2 weeks before the first dose continue to use.
• Have a history of active pulmonary tuberculosis. In patients suspected of having active TB, examination of chest X-ray, sputum, and exclusion by clinical symptoms and signs are required.
• Has an active infection requiring systemic treatment.
• Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence.
• Past history of clear neurological or psychiatric disorders.
• The investigator judged other situations not suitable for inclusion in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

hongqing zhuang

Role: CONTACT

hongqingzhuang@163.com

0086-13051776232

Other Identifiers

ALTER-L056

Identifier Type: -

Identifier Source: org_study_id