Combination of Almonertinib and Concurrent Chemoradiotherapy in Unresectable Stage III NSCLC

NCT04952168 | Unknown Phase 2

• 1 other identifier: TJHCC-ACLC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

NSCLC, Stage III

Keywords

Almonertinib; chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival rate

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

  2 years

Secondary Outcomes (2)

• Progression-free survival

  3 years

• Overall survival

  5 years

Study Arms (1)

Almonertinib group

EXPERIMENTAL

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

Interventions

Almonertinib 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.

Almonertinib group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients progress in 3 months after almonertinib treatment
• Patient can't tolerate radiotherapy or targeted therapy
• Pregnant or nursing women

Sponsors & Collaborators

• Yuan Chen: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• yuan Chen, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan Chen, MD

CONTACT

00862783663407; chenyuan008@163.com

ping Peng, PhD

CONTACT

00862783663407; pengpingtj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of chest oncology, Professor

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: June 2, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

CN (1)