Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Phase 2

• Conditions: NSCLC, Stage III
• Interventions: Drug: Almonertinib

• Registration Number: NCT04952168
• Lead Sponsor: Yuan Chen

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-06-27
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Primary Completion: 2022-06-02
• Study Completion: 2023-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Almonertinib group	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.

Primary Outcome Measures

Name	Time	Method
2-year overall survival rate	2 years	The 2-year overall survival rate was defined as the rate of death within 2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	From the first administration to death from any cause
Progression-free survival	3 years	From the first treatment to the date of first documentation of disease progression, or death due to any cause

Trial Locations

Locations (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China