Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases

NCT06483672 | Not Yet Recruiting Phase 2

• 1 other identifier: 23/469-4212
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if furmonertinib plus anlotinib works to treat participants with lung adenocarcinoma with EGFR mutations and brain metastases. It will also learn about the safety of furmonertinib plus anlotinib. The main questions it aims to answer are:

• Does furmonertinib plus anlotinib increase the number of participants who has a significant tumor shrinkage?
• What medical problems do participants have when taking furmonertinib plus anlotinib? Researchers will evaluate the safety and efficacy of furmonertinib plus anlotinib. Participants will:
• Take furmonertinib(every day) and anlotinib(two weeks on and one week off)
• Visit the clinic once every 3 weeks for checkups and tests.
• Keep a diary of their symptoms.

Conditions

Adenocarcinoma of Lung Metastatic to Brain

Keywords

Adenocarcinoma of Lung; Brain metastasis; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• Central Nervous System Objective Response Rate (CNS ORR)

  Proportion of subjects whose CNS tumors are assessed as complete response(CR) or partial response(PR) according to RANO-BM.

  Approximately 12 weeks after the last patient begin study treatment

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Approximately 12 weeks after the last patient begin study treatment

• Disease Control Rate (DCR)

  Approximately 12 weeks after the last patient begin study treatment

• Progression Free Survival (PFS)

  Approximately 18 months after the first patient begin study treatment

• Overall survival (OS)

  Approximately 24 months after the last patient begin study treatment

• Central Nervous System Disease Control Rate (CNS DCR)

  Approximately 12 weeks after the last patient begin study treatment

Other Outcomes (1)

• Change from baseline and time to deterioration in gene mutation spectrum of ctDNA

  Approximately 18 months from the last patient begin study treatment

Study Arms (1)

Furmonertinib combine with anlotinib

EXPERIMENTAL

Furmonertinib 80mg, once daily, orally Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally

Drug: Furmonertinib; Drug: Anlotinib

Interventions

Furmonertinib DRUG

Furmonertinib 80mg, once daily, orally

Also known as: AST2818

Furmonertinib combine with anlotinib

Anlotinib DRUG

Anlotinib 12mg, once daily (days 1-14, 21 days per cycle), orally

Also known as: No other intervention names

Furmonertinib combine with anlotinib

Eligibility Criteria

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

You may qualify if:

• Male or Female aged ≥18 years old;
• Histologically or cytopathologically confirmed non-small cell lung cancer (NSCLC) ;
• According to RANO-BM, the subject has at least 1 intracranial measurable lesion;
• Tumor tissue samples or blood samples are confirmed to be EGFR mutations;
• ECOG PS 0-1;
• Life expectancy \>12 weeks;
• No prior systemic antitumor therapy for metastatic NSCLC

You may not qualify if:

• Patients without lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type, etc;
• Expected to receive other anti-tumor therapy other than the investigational product during the study;
• Having previously received systematic anti-tumor therapy
• Having received the following therapies: (1) Having been irradiated for \> 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product; (2) Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy; (3) Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product or a potent CYP3A4 inducer within 21 days prior to the first dose of investigational product; use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study; (4) Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product; (5) Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product;
• Having a history of other malignant tumor, or other concurrent malignant tumors;
• The toxicity caused by previous anti-tumor therapy has not recovered to \<= CTCAE grade 1 (CTCAE 5.0) (except alopecia, sequelae of previous platinum-related neurotoxicity) ;
• Previous interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected interstitial lung disease;
• Serious gastrointestinal dysfunction, or disease that may affect the intake, transportation or absorption of investigational product;
• Recently active digestive disease
• The patient is prone to bleeding or has active bleeding; Any bleeding event ≥CTCAE grade 3 within 28 days prior to the first study drug;
• Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval; for example, QTc \> 470 ms on ECG at resting state, complete left bundle branch block, degree III atrioventricular block, congenital long QT syndrome, serious hypokalemia, or current use of drugs that may lead to prolonged QT interval;
• Bone marrow reserve, liver, kidney organs and other functions are insufficient;
• There has been an active venous thrombosis event within the last 6 months;
• Known Active hepatitis B virus , hepatitis C virus (positive HCV Ab) or human immunodeficiency virus (positive HIV antibody) infection;
• Infectious disease requiring intravenous medication;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Adenocarcinoma of Lung; Brain Neoplasms

Interventions

aflutinib; anlotinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sheng Yang, Doctor

  Cancer Hospital, CAMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Yang, Doctor

CONTACT

010-87788507; medart@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share