Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04952168

Enrollment

Registered

2021-07-07

Start date

2021-06-02

Completion date

2023-06-02

Last updated

2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC, Stage III

Keywords

Almonertinib, chemoradiotherapy

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

Interventions

DRUGAlmonertinib

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary Contactyuan Chen, MD

chenyuan008@163.com00862783663407

Backup Contactping Peng, PhD

pengpingtj@163.com00862783663407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026