To Evaluate the Efficacy and Safety of Anlotinib Combined With Furmonertinib Mesylate in Lung Cancer

NCT04671303 | Completed Phase 2

• 1 other identifier: ALTN-AFTN-II-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy of drug therapy

  The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;

  up to 4 weeks

Secondary Outcomes (1)

• The overall efficacy was assessed by the investigators

  up to 48 weeks

Study Arms (1)

Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate

EXPERIMENTAL

Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle.

Drug: Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate

Interventions

Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate DRUG

Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle.

Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate

Eligibility Criteria

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

You may qualify if:

• Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
• Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0\~1; The expected survival time is more than 3 months;
• The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
• There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
• The main organs are functioning well,Adequate laboratory indicators.
• Patients voluntarily participated in this study, signed informed consent, and had good compliance.

You may not qualify if:

• Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
• Received chemical or biological drugs after the diagnosis of advanced stage;
• Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
• Within 2 weeks before the start of the study, patients were treated with Chinese medicines
• Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
• Brain metastases with symptoms or symptom control time less than 2 weeks;

Sponsors & Collaborators

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

Study Sites (1)

cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aflutinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuankai SHI, Doctor

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 27, 2023
• Last Updated: May 11, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)