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Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC (FOCUS-A)

Primary Purpose

Non-Small-Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Furmonertinib
Anlotinib
Sponsored by
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring EGFR mutations; furmonertinib; anlotinib; non-squamous NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects have voluntarily participated, signed and dated informed consent;
  2. Male or female subjects aged ≥18 and ≤75 years old;
  3. Locally advanced or metastatic adenocarcinoma NSCLC confirmed by histology or cytology (according to the 8th Edition of the AJCC Staging system), not suitable for surgery or radiotherapy;
  4. ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
  5. The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
  6. According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
  7. No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment;
  8. Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
  9. For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

Exclusion Criteria:

  1. Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
  2. Subjects are expected to participate in other clinical studies during this trial period;
  3. Imaging evidence showed that the tumor had invaded critical blood vessels;
  4. Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
  5. With other malignant tumors at present or history of other malignant tumors within 5 years;
  6. Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
  7. At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
  8. History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
  9. Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
  10. Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
  11. Presence of bleeding constitution or active bleeding; any bleeding event ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose;
  12. Any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): Absolute value of neutrophil (NE)<1.5 × 109/L, platelet (PLT) count<90 × 109/L, hemoglobin (HGB)<90 g/L; Serum total bilirubin (TBIL)>1.5 × ULN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN (for liver metastases or Gilbert Syndrome, TBIL>3 × ULN, and AST and/or ALT>5 × ULN); Serum creatinine (SCr)>1.5 × ULN, or creatinine clearance<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein>1.0g; International normalized ratio(INR)>1.5 and activated partial thromboplastin time (APTT)>1.5 ULN; Fasting blood glucose >10mmol/L;
  13. Any of the following cardiac criteria is met:

    • At rest, the mean corrected QT interval (QTc) by ECG > 470 msec;
    • Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG;
    • Any factors that may increase the risk of prolonged QTc or risk of arrhythmic events;
    • Left ventricular ejection fraction (LVEF) < 50%;
    • Uncontrollable hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥100 mmHg);
  14. With active infection diseases, such as HBV, HCV and HIV;
  15. Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations;
  16. Pregnancy or lactation;
  17. Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furmonertinib Plus Anlotinib

Arm Description

Furmonertinib (80mg) plus Anlotinib (10mg)

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.

Secondary Outcome Measures

Disease Control Rate (DCR)
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
Duration of Response (DOR)
The time from objective tumor remission (CR or PR) to the progression of the disease or death for any reason.
Disease progression free survival (PFS)
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Adverse Events
Number of participants with adverse events as a measure of safety and tolerability.

Full Information

First Posted
May 19, 2021
Last Updated
January 5, 2023
Sponsor
Shanghai Chest Hospital
Collaborators
Allist Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04895930
Brief Title
Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
Acronym
FOCUS-A
Official Title
A Multi-center, One-arm Clinical Trial of Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
Collaborators
Allist Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib combined with Anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive EGFR mutations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer
Keywords
EGFR mutations; furmonertinib; anlotinib; non-squamous NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Furmonertinib Plus Anlotinib
Arm Type
Experimental
Arm Description
Furmonertinib (80mg) plus Anlotinib (10mg)
Intervention Type
Drug
Intervention Name(s)
Furmonertinib
Other Intervention Name(s)
AST2818
Intervention Description
80mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (40mg).
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
10mg/day orally from day 1 to 14 of a 21-day cycle. If subjects suffer from AEs, they can get declined dosage (8mg).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Time Frame
Approximately 3 years following the first dose of study drugs
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
Time Frame
Approximately 3 years following the first dose of study drugs
Title
Duration of Response (DOR)
Description
The time from objective tumor remission (CR or PR) to the progression of the disease or death for any reason.
Time Frame
Approximately 3 years following the first dose of study drugs
Title
Disease progression free survival (PFS)
Description
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Time Frame
Approximately 3 years following the first dose of study drugs
Title
Adverse Events
Description
Number of participants with adverse events as a measure of safety and tolerability.
Time Frame
Until 30 days from the last dose of study drugs or initiation of a new anticancer treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects have voluntarily participated, signed and dated informed consent; Male or female subjects aged ≥18 and ≤75 years old; Locally advanced or metastatic adenocarcinoma NSCLC confirmed by histology or cytology (according to the 8th Edition of the AJCC Staging system), not suitable for surgery or radiotherapy; ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment; The tumour harbours one of the most common EGFR mutations (19del or L858R) ; According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously; No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment; Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment; For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose. Exclusion Criteria: Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc; Subjects are expected to participate in other clinical studies during this trial period; Imaging evidence showed that the tumor had invaded critical blood vessels; Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously; With other malignant tumors at present or history of other malignant tumors within 5 years; Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment; At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1; History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors; Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs; Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation; Presence of bleeding constitution or active bleeding; any bleeding event ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose; Any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): Absolute value of neutrophil (NE)<1.5 × 109/L, platelet (PLT) count<90 × 109/L, hemoglobin (HGB)<90 g/L; Serum total bilirubin (TBIL)>1.5 × ULN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN (for liver metastases or Gilbert Syndrome, TBIL>3 × ULN, and AST and/or ALT>5 × ULN); Serum creatinine (SCr)>1.5 × ULN, or creatinine clearance<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein>1.0g; International normalized ratio(INR)>1.5 and activated partial thromboplastin time (APTT)>1.5 ULN; Fasting blood glucose >10mmol/L; Any of the following cardiac criteria is met: At rest, the mean corrected QT interval (QTc) by ECG > 470 msec; Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG; Any factors that may increase the risk of prolonged QTc or risk of arrhythmic events; Left ventricular ejection fraction (LVEF) < 50%; Uncontrollable hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥100 mmHg); With active infection diseases, such as HBV, HCV and HIV; Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations; Pregnancy or lactation; Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han, MD
Phone
+86 021-22200000
Email
xkyyhan@gmail.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han

12. IPD Sharing Statement

Citations:
PubMed Identifier
33780662
Citation
Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.
Results Reference
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Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

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