Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Study Overview
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Brief Summary
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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

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

Conditions
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NSCLC, Stage III

Intervention / Treatment
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* Drug: Almonertinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almonertinib group<br>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. | Drug: Almonertinib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival rate | The 2-year overall survival rate was defined as the rate of death within 2 years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | From the first treatment to the date of first documentation of disease progression, or death due to any cause | 3 years | 
| Overall survival | From the first administration to death from any cause | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Almonertinib, chemoradiotherapy