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

September 2, 2021 updated by: Lili Cao, Qianfoshan Hospital

Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated，Advanced Non-small Cell Lung Cancer, a Randomized，Controlled，Phase II Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, +86250001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Almonertinib plus Microwave ablation group
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.
Combination product: Almonertinib plus microwave ablation
Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
Other Names:
  • Microwave ablation
ACTIVE_COMPARATOR: Almonertinib group
Patients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events.
Combination product: Almonertinib plus microwave ablation
Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
Other Names:
  • Microwave ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
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.
progression free survival
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 Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From the date of randomization to the date of death, assessed up to 36 months.
overall survival
From the date of randomization to the date of death, assessed up to 36 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: From the date of randomization to the date of disease progression or death，whichever came first, assessed up to 36 months.
adverse events
From the date of randomization to the date of disease progression or death，whichever came first, assessed up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Collaborators

Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2022

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

March 31, 2025

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QianfoshanH O

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It depends.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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