Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

NSCLC, Stage III Clinical Trial

Official title:

A Single Arm, Prospective, Open Clinical Study of Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC With EGFR Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952168
• Other study ID #: TJHCC-ACLC
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: July 2021
• Source: Tongji Hospital
• Contact: yuan Chen, MD
• Phone: 00862783663407
• Email: chenyuan008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18, male or female.

2. Patients must provide written informed consent to participate in the study.

3. Patients must have biopsy proven unresectable stage III NSCLC (AJCC 8th).

4. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R).

5. Patients receiving almonertinib for 3 months and achieved stable disease, partial response or completely response.

6. ECOG score 0-1

7. Demonstrate adequate organ function Patients evaluated as Cr, PR and SD were given concurrent chemoradiotherapy 3 months after targeted therapy

Exclusion Criteria:

1. Patients progress in 3 months after almonertinib treatment

2. Patient can't tolerate radiotherapy or targeted therapy

3. Pregnant or nursing women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC, Stage III

Intervention

Drug:
• Almonertinib
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.

Locations

Country	Name	City	State
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Yuan Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival rate	The 2-year overall survival rate was defined as the rate of death within 2 years	2 years
Secondary	Progression-free survival	From the first treatment to the date of first documentation of disease progression, or death due to any cause	3 years
Secondary	Overall survival	From the first administration to death from any cause	5 years