NCT04755738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

February 7, 2021

Last Update Submit

September 2, 2021

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

non small cell lung cancermicrowave ablationepidermal growth factor receptorprogression free survivaloverall survival

Outcome Measures

Primary Outcomes (1)

  • PFS

    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 Outcomes (1)

  • OS

    From the date of randomization to the date of death, assessed up to 36 months.

Other Outcomes (1)

  • AE

    From the date of randomization to the date of disease progression or death，whichever came first, assessed up to 36 months.

Study Arms (2)

Almonertinib plus Microwave ablation group

EXPERIMENTAL

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

Almonertinib group

ACTIVE COMPARATOR

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

Interventions

Almonertinib plus microwave ablationCOMBINATION_PRODUCT

Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.

Also known as: Microwave ablation
Almonertinib groupAlmonertinib plus Microwave ablation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin Ye

Jinan, SD, +86250001, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Xin Ye

CONTACT

+86 53189268553yexintaian2020@163.com

Zhigang Wei

CONTACT

+86 53189268553weizhigang321321@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department of oncology

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 16, 2021

Study Start

January 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2025

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

It depends.

Locations

CN(1)