Back to resultsCombination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
Primary Purpose
NSCLC, Stage III
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Almonertinib
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC, Stage III focused on measuring Almonertinib, chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Age ≥18, male or female.
- Patients must provide written informed consent to participate in the study.
- Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).
- Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).
- Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.
- ECOG score 0-1
- Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy
Exclusion Criteria:
- Patients progress in 3 months after almonertinib treatment
- Patient can't tolerate radiotherapy or targeted therapy
- Pregnant or nursing women
Sites / Locations
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Almonertinib group
Arm Description
All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.
Outcomes
Primary Outcome Measures
2-year overall survival rate
The 2-year overall survival rate was defined as the rate of death within 2 years
Secondary Outcome Measures
Progression-free survival
From the first treatment to the date of first documentation of disease progression, or death due to any cause
Overall survival
From the first administration to death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04952168
Brief Title
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
Official Title
A Single Arm, Prospective, Open Clinical Study of Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC With EGFR Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Anticipated)
Study Completion Date
June 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuan Chen
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
This is a Prospective, open, single arm study to evaluate the efficacy and safety of the almonertinib combined with concurrent chemoradiotherapy in unresectable stage III NSCLC with EGFR mutation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC, Stage III
Keywords
Almonertinib, chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Almonertinib group
Arm Type
Experimental
Arm Description
All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.
Intervention Type
Drug
Intervention Name(s)
Almonertinib
Intervention Description
All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.
Primary Outcome Measure Information:
Title
2-year overall survival rate
Description
The 2-year overall survival rate was defined as the rate of death within 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
From the first treatment to the date of first documentation of disease progression, or death due to any cause
Time Frame
3 years
Title
Overall survival
Description
From the first administration to death from any cause
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18, male or female.
Patients must provide written informed consent to participate in the study.
Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).
Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).
Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.
ECOG score 0-1
Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy
Exclusion Criteria:
Patients progress in 3 months after almonertinib treatment
Patient can't tolerate radiotherapy or targeted therapy
Pregnant or nursing women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yuan Chen, MD
Phone
00862783663407
Email
chenyuan008@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
ping Peng, PhD
Phone
00862783663407
Email
pengpingtj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yuan Chen, MD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ping Peng, PhD
Phone
13429818576
Email
pengpingtj@163.com
12. IPD Sharing Statement
Learn more about this trial
Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC
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