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Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer (MWA)

Primary Purpose

Advanced Non Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Almonertinib plus microwave ablation
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, microwave ablation, epidermal growth factor receptor, progression free survival, overall survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologically verified non-small-cell lung cancer;
  2. Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
  3. EGFR Exon 19del or Exon 21 L858R mutations;
  4. No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
  5. ECOG PS 0-1;
  6. Anticipated survival time ≥3 months;
  7. At least one measurable lesions (according to RECIST 1.1, CT scan length ≥10mm, CT scan short diameter ≥15mm) except the ablation lesions (primary lesion or the largest recurrent lesion) ;
  8. Asymptomatic brain metastasis;
  9. The routine laboratory examination was normal (blood routine, liver and kidney function, blood coagulation function, etc The standard of blood routine examination should be met (No blood transfusion and blood products within 14 days) ; ANC≥1.5×109/L; PLT ≥80×109/L. B. Biochemical examination should meet the following criteria: TBIL≤ 1.5 ULN; ALT, Ast ≤ 2.5 ULN).
  10. Adequate tissue specimens for further analysis.
  11. Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during and within 1 month after the end of the study period; The serum or urine HCG test must be negative within 72 hours before admission to the study, and must be non-lactation period; (12)18-80 years old;

(13)Patients signed informed consent;

Exclusion Criteria:

  1. Mixed lung cancer including neuroendocrine or small-cell lung cancer;
  2. Multiprimary tumors during the past 5 years;
  3. Uncontrolled pleural or pericardial effusion;
  4. Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
  5. A severe infection (CTCAE > 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
  6. baseline chest radiographic examination revealed active pulmonary inflammation.
  7. The patients experienced acute cardiac cerebrovascular disease such as acute cerebral infarction and acute coronary syndrome within 1 month, (8) The cardiovascular clinical symptoms or diseases were not well controlled, including the following cases: There is local active Ulcer Focus, and stool occult blood {(+ +) can not be included in the group } ; within 2 months, there are black stool, hematemesis history;
  8. Abnormal coagulation function with bleeding tendency;
  9. Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (Hepatitis B reference: HBV DNA test above the normal limit; Hepatitis C reference: HCV virus or RNA test above the normal limit) ;
  10. Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;

Sites / Locations

  • Xin Ye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Almonertinib plus Microwave ablation group

Almonertinib group

Arm Description

Patients in the group were treated with both targeted therapy and microwave ablation. Patients were treated with Almonertinib with the dose of 110mg once daily firstly. When the best response achieved, microwave ablation was conducted in the primary tumors, and then followed by Almonertinib treatments.

Patients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events.

Outcomes

Primary Outcome Measures

PFS
progression free survival

Secondary Outcome Measures

OS
overall survival

Full Information

First Posted
February 7, 2021
Last Updated
September 2, 2021
Sponsor
Qianfoshan Hospital
Collaborators
Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04755738
Brief Title
Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer
Acronym
MWA
Official Title
Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated,Advanced Non-small Cell Lung Cancer, a Randomized,Controlled,Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital
Collaborators
Shandong Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial.
Detailed Description
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial. Patients were assigned into two groups.In the experiment group, patients were treated with both Almonertinib and microwave ablation. In the control group, patients were treated with Almonertinib alone. The primary end point was progression free survival. Second endpoints included overall survival and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer
Keywords
non small cell lung cancer, microwave ablation, epidermal growth factor receptor, progression free survival, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Almonertinib plus Microwave ablation group
Arm Type
Experimental
Arm Description
Patients in the group were treated with both targeted therapy and microwave ablation. Patients were treated with Almonertinib with the dose of 110mg once daily firstly. When the best response achieved, microwave ablation was conducted in the primary tumors, and then followed by Almonertinib treatments.
Arm Title
Almonertinib group
Arm Type
Active Comparator
Arm Description
Patients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events.
Intervention Type
Combination Product
Intervention Name(s)
Almonertinib plus microwave ablation
Other Intervention Name(s)
Microwave ablation
Intervention Description
Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
Primary Outcome Measure Information:
Title
PFS
Description
progression free survival
Time Frame
From the date of randomization to the date of disease progression or death for any causes,whichever came first, assessed up to 36 months.
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From the date of randomization to the date of death, assessed up to 36 months.
Other Pre-specified Outcome Measures:
Title
AE
Description
adverse events
Time Frame
From the date of randomization to the date of disease progression or death,whichever came first, assessed up to 36 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically verified non-small-cell lung cancer; Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ; EGFR Exon 19del or Exon 21 L858R mutations; No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ; ECOG PS 0-1; Anticipated survival time ≥3 months; At least one measurable lesions (according to RECIST 1.1, CT scan length ≥10mm, CT scan short diameter ≥15mm) except the ablation lesions (primary lesion or the largest recurrent lesion) ; Asymptomatic brain metastasis; The routine laboratory examination was normal (blood routine, liver and kidney function, blood coagulation function, etc The standard of blood routine examination should be met (No blood transfusion and blood products within 14 days) ; ANC≥1.5×109/L; PLT ≥80×109/L. B. Biochemical examination should meet the following criteria: TBIL≤ 1.5 ULN; ALT, Ast ≤ 2.5 ULN). Adequate tissue specimens for further analysis. Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during and within 1 month after the end of the study period; The serum or urine HCG test must be negative within 72 hours before admission to the study, and must be non-lactation period; (12)18-80 years old; (13)Patients signed informed consent; Exclusion Criteria: Mixed lung cancer including neuroendocrine or small-cell lung cancer; Multiprimary tumors during the past 5 years; Uncontrolled pleural or pericardial effusion; Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung; A severe infection (CTCAE > 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; baseline chest radiographic examination revealed active pulmonary inflammation. The patients experienced acute cardiac cerebrovascular disease such as acute cerebral infarction and acute coronary syndrome within 1 month, (8) The cardiovascular clinical symptoms or diseases were not well controlled, including the following cases: There is local active Ulcer Focus, and stool occult blood {(+ +) can not be included in the group } ; within 2 months, there are black stool, hematemesis history; Abnormal coagulation function with bleeding tendency; Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (Hepatitis B reference: HBV DNA test above the normal limit; Hepatitis C reference: HCV virus or RNA test above the normal limit) ; Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Ye
Phone
+86 53189268553
Ext
1
Email
yexintaian2020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhigang Wei
Phone
+86 53189268553
Email
weizhigang321321@163.com
Facility Information:
Facility Name
Xin Ye
City
Jinan
State/Province
Shandong
ZIP/Postal Code
+86250001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Ye
Email
yexitaian2020@163.com
First Name & Middle Initial & Last Name & Degree
Xin Ye

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It depends.

Learn more about this trial

Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer

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