Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

Yuan Chen

Status and phase: Unknown; Phase 2

Conditions: NSCLC, Stage III

Treatments: Drug: Almonertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04952168

TJHCC-ACLC

Details and patient eligibility

About

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

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Almonertinib group

Experimental group

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.

Treatment:

Drug: Almonertinib