A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636593
• Other study ID #: AlmonTRT
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: First People's Hospital of Hangzhou
• Contact: Shenglin Ma, M.D
• Phone: 086-0571-56006013
• Email: Mashenglin[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.

Description:

Doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage III NSCLC patients, regardless of the EGFR mutation status. But the 5-year survival rate is not satisfying. Previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination TKI with radiotherapy. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in EGFR-sensitive mutated locally advanced NSCLC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed histologically or pathologically as non-small cell lung cancer;
• According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
• Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
• Have not received systemic anti-tumor therapy;
• FEV1>0.75L;
• Age = 18 years old;
• ECOG PS score = 2;
• Estimated survival period = 6 months;
• Women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end;
• Sign the informed consent form.

Exclusion Criteria:

• Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
• Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
• Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
• Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
• It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;
• Currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago);
• The patient is taking any drugs that prolong the QT interval, and the drug cannot be stopped before the treatment of almonertinib;
• Patients with lung V20 > 28% even after two-month almonertinib treatment.
• Pregnancy or breastfeeding.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Activating Mutation
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Stage III NSCLC

Intervention

Drug:
• Almonertinib
All enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 = 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.

Locations

Country	Name	City	State
China	Hangzhou Cancer hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Hangzhou Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP(=3)	incidence of radiation pneumonitis (= grade 3) within 6 month after Radiotherapy	6 months
Secondary	LCR	local control rate	1 years
Secondary	PFS	progression-free survival (PFS) defines as intervals from treatment to disease progression or death	2 years
Secondary	OS	overall survival (OS) intervals from treatment to death or last follow-uo	2 years