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

Primary Purpose

Non Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Almonertinib
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring radiotherapy, radiation pneumonitis, almonertinib, lung cancer, EGFR-TKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hangzhou Cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Induction group

Concurrent group

Arm Description

If the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy

If the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib.

Outcomes

Primary Outcome Measures

RP(≥3)
incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy

Secondary Outcome Measures

LCR
local control rate
PFS
progression-free survival (PFS) defines as intervals from treatment to disease progression or death
OS
overall survival (OS) intervals from treatment to death or last follow-uo

Full Information

First Posted
November 15, 2020
Last Updated
January 8, 2021
Sponsor
First People's Hospital of Hangzhou
Collaborators
Hangzhou Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04636593
Brief Title
A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC
Official Title
Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First People's Hospital of Hangzhou
Collaborators
Hangzhou Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Stage III NSCLC, EGFR Activating Mutation
Keywords
radiotherapy, radiation pneumonitis, almonertinib, lung cancer, EGFR-TKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction group
Arm Type
Experimental
Arm Description
If the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy
Arm Title
Concurrent group
Arm Type
Experimental
Arm Description
If the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib.
Intervention Type
Drug
Intervention Name(s)
Almonertinib
Other Intervention Name(s)
Thoracic Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
RP(≥3)
Description
incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
LCR
Description
local control rate
Time Frame
1 years
Title
PFS
Description
progression-free survival (PFS) defines as intervals from treatment to disease progression or death
Time Frame
2 years
Title
OS
Description
overall survival (OS) intervals from treatment to death or last follow-uo
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenglin Ma, M.D
Phone
086-0571-56006013
Email
Mashenglin@medmail.com.cn
Facility Information:
Facility Name
Hangzhou Cancer hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Xia, M.D
Phone
086-0571-56006388
Email
bxia_hzch@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33962566
Citation
Zhu L, Zou C, Zhang Z, Wang J, Yang L, Rao C, Yang Z, Liang J, Xia B, Shenglin MA. Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study. BMC Cancer. 2021 May 7;21(1):511. doi: 10.1186/s12885-021-08266-w.
Results Reference
derived

Learn more about this trial

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

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