SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer

NCT06476093 | Recruiting

• 1 other identifier: KY-20231219001-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.

Conditions

Non-Small-Cell Lung Cancer; Brain Metastases

Keywords

Anlotinib; SRT; Non-Small-Cell Lung Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (2)

• intracerebral Progression-Free-Surviva（iPFS）

  The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason The time from the start of treatment to intracranial tumor progression or death for any reason

  20 months

• intracerebral Objective Response Rate (iORR)

  The proportion of patients whose intracranial tumor volume has reduced to a predetermined value and can maintain the minimum time limit

  20 months

Secondary Outcomes (6)

• intracerebral Progression-Free-Survival rate at 6 months and 1 year

  12 months

• Progression-Free-Survival（PFS）

  20 months

• Objective Response Rate（ORR）

  20 months

• intracerebral Disease Control Rate（iDCR）

  20 months

• Disease Control Rate（DCR）

  20 months

Study Arms (1)

Anlotinib+SRT Group

EXPERIMENTAL

Anlotinib#12mg#PO#Q3W#d1-14#

Drug: Anlotinib hydrochloride

Interventions

Anlotinib hydrochloride DRUG

Anlotinib#12mg#PO#Q3W#d1-14# SRT#depends

Also known as: SRT

Anlotinib+SRT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in this study, sign informed consent, and demonstrate good compliance.
• Patients with histologically or pathologically confirmed EGFR wild-type and EGFR mutant non-small cell lung cancer resistant to treatment.
• The number of brain metastases is ≤ 5, and the patient has at least one assessable brain metastasis on imaging (RECIST 1.1). Additionally, the patient's physical condition allows for the completion of stereotactic radiosurgery.
• Age between 18-80 years, gender unspecified.
• ECOG performance status of 0 or 1; expected survival of no less than 3 months.
• Regardless of prior treatment, it is only required that concurrent oral administration of anlotinib during radiotherapy without intervention regarding subsequent treatment regimens.
• Oral administration of anlotinib including, but not limited to, third-line therapy.
• Good function of major organs, with laboratory test indicators meeting the following criteria:
• <!-- -->
• Hematological examination:
• Hemoglobin (Hb) ≥ 90g/L (no blood transfusion within 14 days);
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; total white blood cell count ≥ 3.5×10\^9/L;
• Platelets (PLT) ≥ 100×10\^9/L;
• Blood biochemistry examination:
• a、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastasis/bone metastasis; ≤ 5 ULN for tumor bone metastasis); b、Total bilirubin (TBIL) ≤ 1.5 × ULN; c、Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 60 ml/min;

You may not qualify if:

• Squamous cell carcinoma patients (including adenosquamous carcinoma patients) should be excluded under the following conditions:
• ① Cavitary lung cancer.
• ② Patients who have had hemoptysis within the last month before the first dose and with a maximum daily hemoptysis of ≥2.5 mL, as well as other significant clinically relevant bleeding symptoms or those with a clear bleeding tendency combined with diseases/history.
• Patients with diffuse pleural metastases, malignant pericardial effusion, or diffuse spinal cord involvement.
• Patients with a history of other malignancies within 5 years (excluding cured basal cell carcinoma of the skin, prostate intraepithelial neoplasia, and cervical intraepithelial neoplasia).
• Current presence of pulmonary pneumonia with CTCAE 5.0 grade ≥ 2.
• Individuals with various factors that affect oral medication (such as dysphagia, gastrointestinal resection, chronic diarrhea, and intestinal obstruction).
• Evidence of active bleeding, or unexplained persistent decrease in hemoglobin. Screening/enrollment should be postponed until bleeding stops and the investigator deems it safe.
• Within the first 4 weeks before the initial dose, occurrence of any bleeding or hemorrhagic event ≥ Grade 3 according to CTCAE 5.0 standards; use of anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar agents for treatment; under the condition that prothrombin time international normalized ratio (INR) ≤ 1.5, allowing the use of low-dose warfarin for prophylactic purposes (≤ 1mg/d), low-dose heparin (≤ 12,000 U/d), or low-dose aspirin (≤ 100mg/d).
• Within the 4 weeks before the initial dose, the presence of unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis, or active bleeding from unresected tumors, or conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation; or patients who have undergone major surgeries (excluding vascular access surgery).
• Receipt of traditional Chinese medicine listed in the NMPA-approved drug instructions, which explicitly have indications for anti-tumor and lung cancer treatment (including compound Bupleurum capsules, Kangai injection, Conlear capsules/injections, Edaravone injections, Yadanzi oil injections/capsules, Xiaocanping tablets/injections, HuaChanSu capsules), or immune modulating drugs (excluding local use for pleural effusion control) within 2 weeks before the initial dose.
• History of organ or hematologic system transplantation.
• Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction.
• Patients with severe and/or uncontrolled diseases, including:
• Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥90mmHg);

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Study Sites (1)

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222002, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xiaodong Jiang, Doc

  THE FIRST PEOPLE'S HOSPITAL OF LAINYUNGANG

  STUDY CHAIR

Central Study Contacts

Xiaodong Jiang, Doc

CONTACT

86-0518-85469074; jxdysy1970@163.com

Xiaodong Jiang, Doc

CONTACT

18961326201; jxdysy1970@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)