Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-02

Study Completion Date

2023-06-02

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

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Detailed Description

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Conditions

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NSCLC, Stage III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Almonertinib group

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.

Group Type EXPERIMENTAL

Almonertinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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